Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

CLIA - Tests waived by FDA from January 2000 to present

see related
Tests can be categorized as "waived" from regulatory oversite if they meet certain requirements established by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) law. By selecting a Test System Name, you can view the CLIA data for that Test System, including the corresponding 510(K) record, if applicable. The information is sorted first by the date of Categorization of the Test, then by Test System Name. This list does not include Test Systems that were characterized by the CDC prior to January 2000.
 
 
 1 
 3 
 A 
 B 
 C 
 D 
 E 
 F 
 G 
 H 
 I 
 J 
 K 
 L 
 M 
 N 
 O 
 P 
 Q 
 R 
 S 
 T 
 U 
 V 
 W 
 Y 
 Z 
 
 
Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Amphetamines Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Cannabinoids (THC) Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Phencyclidine (PCP) Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Cocaine Metabolites Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Opiates Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Propoxyphene Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Benzodiazepines Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Barbiturates Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Tricyclic Antidepressants Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify ER Drug Screen  
K041685 Oxycodone Toxicology / TDM 07/01/2009
Inverness Medical Innovations Signify hCG Urine Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/01/2009
IMI Signify Strep A Dipstick {Inverness Medical Innovations} 
K010582 Streptococcus, Group A Bacteriology 05/21/2009
Inverness Medical SIGNIFY H. PYLORI WHOLE BLOOD  
K024350 Helicobacter Pylori Antibodies General Immunology 05/21/2009
Inverness Medical Signify Strep A Cassette {Inverness Medical Innovations} 
K031784 Streptococcus, Group A Bacteriology 05/21/2009
Inverness Medical Innovations Signify hCG Combo Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 04/30/2009
Innovacon, Inc. One Step hCG Single Test Card  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 03/12/2009
InfopiaUSA, LLC Duo-Max Blood Pressure and Glucose Monitoring System, Model HMF-100  
K080636 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/18/2009
i-SENS, Inc. CareSens N Blood Glucose Monitoring System  
K083468 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/12/2009
IM Diagnostics, Inc. IM Confirms II hCG Pregnancy Urine Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 01/26/2009
Infopia USA Envision Autocode Blood Glucose Monitoring System  
K082020 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/15/2009
IM Diagnostics, Inc. IM Maxie 2 hCG Pregnancy Urine Cassette and Dipstick Tests  
K070921 Urine hCG By Visual Color Comparison Tests Endocrinology 11/04/2008
IM Diagnostics, Inc. IM Confirms II plus hCG Pregnancy Serum/Urine Cassette and Dipstick Tests  
K071030 Urine hCG By Visual Color Comparison Tests Endocrinology 10/28/2008
i-SENS, Inc. CareSens II Blood Glucose Monitoring System  
K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
i-SENS, Inc. CareSens POP Blood Glucose Monitoring System  
K080923 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/23/2008
Inverness Medical Acceava hCG Urine II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 08/14/2008
Inverness Medical Acceava hCG Basic II  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008
Inverness Medical Acceava hCG Combo II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/14/2008
IDEAL LIFE Gluco-Manager GMM 0001 Blood Glucose Monitoring System  
K080283 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/30/2008
Inverness Medical Professional Diagnostics BioStar Acceava hCG Urine II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 03/26/2008
Inverness Medical BioStar Acceava Strep A Twist {Strep A} 
K023766 Streptococcus, Group A Bacteriology 03/19/2008
Inverness Medical Professional Diagnostics Clearview 25 hCG Combo  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/24/2007
Inverness Medical Professional Diagnostics Signify hCG Combo Cassette  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 08/24/2007
Inverness Medical Clearview hCG Combo II  
K062361 Urine hCG By Visual Color Comparison Tests Endocrinology 07/12/2007
Inverness Medical Profesional Diagnostics Signify H. pylori Test  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 06/11/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Amphetamines Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Cannabinoids (THC) Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Phencyclidine (PCP) Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Cocaine Metabolites Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Opiates Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Propoxyphene Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Benzodiazepines Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Barbiturates Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Tricyclic Antidepressants Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 05/24/2007
Innovacon Multi-Clin Drug Screen Test Device  
K041685 Oxycodone Toxicology / TDM 05/24/2007
Immuno Detector Mono {Whole Blood} 
K961024 Infectious Mononucleosis Antibodies (Mono) General Immunology 05/17/2007
Immunostics Detector H. pylori WB {H. pylori Antiboby Test} (For whole blood)
K980798 Helicobacter Pylori Antibodies General Immunology 05/16/2007
Innovacon FOB Flipcard Fecal Occult Blood Test  
K063673 Fecal Occult Blood General Chemistry 03/07/2007
Innovacon Integrated E-Z Split Key Cup II  (Professional Use)
K050878 Amphetamines Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878 Cannabinoids (THC) Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878 Phencyclidine (PCP) Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878 Cocaine Metabolites Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878 Opiates Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878 Methamphetamines Toxicology / TDM 02/22/2007
Innovacon Integrated E-Z Split Key Cup II   (Professional Use)
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 02/22/2007
Inverness Medical Professional Devices Clearview hCG Urine Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Clearview hCG Combo II  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Clearview hCG Urine Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Combo Urine/Serum  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Urine Cassette  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Professional Diagnostics Signify hCG Urine Dipstick  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/13/2007
Inverness Medical Clearview Strep A Exact II Dipstick  
K010582 Streptococcus, Group A Bacteriology 02/08/2007
Inverness Medical Clearview H. pylori Test  (Whole Blood)
K024350 Helicobacter Pylori Antibodies General Immunology 02/07/2007
InSure Quik Fecal Immunochemical Test (F.I.T.)  
K060930 Fecal Occult Blood General Chemistry 01/26/2007
Inverness Medical - BioStar Inc. Acceava hCG Basic II  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 11/14/2006
Innovacon hCG Ultra Test Device  
K062361 hCG, Urine Endocrinology 11/01/2006
Inverness Medical BioStar Acceava Strep A Test  
K010582 Streptococcus, Group A Bacteriology 11/01/2006
i-Sens Inc. CareSense Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 10/02/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana (THC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/08/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)  
K040327 Cannabinoids (THC) Toxicology / TDM 08/08/2006
Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)  
K040327 Cocaine Metabolites Toxicology / TDM 08/08/2006
IRIS vChem 10 SG Urine Chemistry Stips  
K861255 Urine Qualitative Dipstick Bilirubin Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Nitrite Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Specific Gravity Urinalysis 07/13/2006
IRIS vChem 10 SG Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
IRIS vChem 2 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 2 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
IRIS vChem 2 Urine Chemstry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Leukocytes Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
IRIS vChem 6 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ketone Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Bilirubin Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Blood Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Glucose Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Nitrite Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick pH Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Protein Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Urobilinogen Urinalysis 07/13/2006
IRIS vChem 8 Urine Chemistry Strips  
K861255 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 07/13/2006
i-Sense Inc. CareSens Blood Glucose Monitoring System  
K051651 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/07/2006
Immunostics, Inc., hema-screen SPECIFIC Immunochemical Fecal Occult Blood Test  
K060463 Fecal Occult Blood General Chemistry 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Amphetamines Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Cannabinoids (THC) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Phencyclidine (PCP) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Cocaine Metabolites Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Opiates Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
K040629 Methamphetamines Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Amphetamines Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Cannabinoids (THC) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Phencyclidine (PCP) Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Cocaine Metabolites Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Opiates Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Methamphetamines Toxicology / TDM 06/15/2006
Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
K041221 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 06/15/2006
Inverness Medical, Inc. Clearblue Easy Digital Pregnancy Test  
K060128 Urine hCG By Visual Color Comparison Tests Endocrinology 06/01/2006
immoCARE Fecal Occult Blood Test  
K052598 Fecal Occult Blood General Chemistry 03/22/2006
ImmuLab, Inc. One Step Pregnancy Test Strip (Urine)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 02/22/2006
Instant Technologies Inc. One Step LH Ovulation Test Cassette  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006
Instant Technologies Inc. One Step LH Ovulation Test Strip  
X050002 Ovulation Test (LH) By Visual Color Comparison Endocrinology 02/22/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-6 Parameters Glucose/Protein/pH/Blood/Ketone/Bilirubin  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-7 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-8 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Blood Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick pH Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Protein Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/09/2006
IND Diagnostic Inc. Urinalysis Reagent Strips-9 Parameters Glucose/Protein/pH/Blood/Ketone/Leukocyte/ Nitrite/ Specific Gravity/ Urobilinogen  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/09/2006
IND Diagnostic Inc. One Step HCG Pregnancy Test 2000 mIU/mL  
K052694 Urine hCG By Visual Color Comparison Tests Endocrinology 12/19/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Cassette)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (midstream)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic INC. One Step FSH Menopausal Test (Strip)  
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic, Inc. One Step Cassette Style FSH Menopausal Test  (Professional Use)
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic, Inc. One Step Strip Style FSH Menopausal Test  (Professional Use)
K052662 Follicle Stimulating Hormone (FSH) Endocrinology 12/02/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Glucose  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-1 Parameter Ketone  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Ketone  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-2 Parameters Glucose/Protein  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-3 Parameters Glucose/Ketone/Protein  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/Nitrite/Leukocytes  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick pH Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-4 Parameters Glucose/Protein/pH/Blood  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Blood Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick pH Urinalysis 11/29/2005
IND Diagnostic Inc. Urinalysis Reagent Strips-5 Parameters Glucose/Protein/pH/Blood/Ketone  
K993850 Urine Qualitative Dipstick Protein Urinalysis 11/29/2005
Instant Technologies iScreen Mononucleosis Rapid Test Device  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/07/2005
Instant Technologies iScreen Mononucleosis Rapid Test Strip  (Whole Blood)
K042272 Infectious Mononucleosis Antibodies (Mono) General Immunology 10/07/2005
Instant Technologies iScreen H. pylori Rapid Test Device  
K024350 Helicobacter Pylori Antibodies General Immunology 09/27/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Ketone Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Bilirubin Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Blood Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Glucose Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Leukocytes Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Nitrite Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick pH Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Protein Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Urobilinogen Urinalysis 09/09/2005
International Newtech Develop. Urinalysis Reagent Strips  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 09/09/2005
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Home Use} 
K051285 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2005
Infopia Co., Ltd. GLucoLab Blood Glucose Monitoring System {Professional Use} 
K051285 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/09/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Amphetamines Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Cannabinoids (THC) Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Phencyclidine (PCP) Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Cocaine Metabolites Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Opiates Toxicology / TDM 07/08/2005
iCassette Multi-Drug, Multi-Line Screen Test Device  
K050050 Methamphetamines Toxicology / TDM 07/08/2005
IND Diagnostic One Step hCG Pregnancy Test - Cassette Format  
K050741 Urine hCG By Visual Color Comparison Tests Endocrinology 05/12/2005
Instant Technologies Inc. One Step hCG Pregnancy Urine Test Cassette  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
Instant Technologies, Inc. One Step hCG Pregnancy Urine Test Strip  
K951705 Urine hCG By Visual Color Comparison Tests Endocrinology 03/16/2005
Inverness Medical, Clearview Mono-plus II  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 03/08/2005
Immunostics Immuno hCG Detector  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
Immunostics Immuno hCG Detector Combi  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
Immunostics Immuno hCG Detector Stix Test  
K041728 Urine hCG By Visual Color Comparison Tests Endocrinology 02/15/2005
INVERNESS MEDICAL SIGNIFY HCG CARD PREGNANCY TEST  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 01/27/2005
INVERNESS MEDICAL SIGNIFY HCG URINE/SERUM PREGNANCY TEST  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 01/27/2005
INVERNESS MEDICAL SIGNIFY HCG-URINE PREGNANCY TEST  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 01/27/2005
Inverness Medical, Signify Mono Test  
K973559 Infectious Mononucleosis Antibodies (Mono) General Immunology 01/10/2005
Inverness Medical, Signify Strep A Dipstick  
K033855 Streptococcus, Group A Bacteriology 01/10/2005
IMMUNOSTICS DETECTOR STREP A DIRECT  
K023766 Streptococcus, Group A Bacteriology 06/28/2004
IND DIAGNOSTIC ONE STEP LH OVULATION TEST  
K040626 Ovulation Test (LH) By Visual Color Comparison Endocrinology 03/25/2004
INSTANT TECHNOLOGIES ISTEP ONE STEP STREP A  
K023766 Streptococcus, Group A Bacteriology 09/25/2003
INTEGRATED BIOTECHNOLOGY QUICK LAB RSV TEST  
K021789 Respiratory Syncytial Virus Virology 08/29/2003
INSTANT TECHNOLOGIES IOVULATION MIDSTEAM OVULATION TEST  
K012252 Ovulation Test (LH) By Visual Color Comparison Endocrinology 07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY HCG URINE PREGNANCY TEST  
K993317 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY HCG URINE/SERUM PREGRANCY TEST  
K993065 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
INSTANT TECHNOLOGIES IPREGNANCY PREGNANCY TEST STRIP (URINE)  
K993203 Urine hCG By Visual Color Comparison Tests Endocrinology 07/11/2003
INSTANT TECHNOLOGIES, ISTREP STREP A  
K010582 Streptococcus, Group A Bacteriology 07/03/2003
INSTANT TECHNOLOGIES HCG ONE STEP PREGNANCY TEST STRIP (URINE/SERUM)  
K980736 Urine hCG By Visual Color Comparison Tests Endocrinology 05/23/2003
INSTANT TECHNOLOGIES IPREGNANCY MIDSTREAM PREGNANCY TEST  
K983090 Urine hCG By Visual Color Comparison Tests Endocrinology 05/12/2003
INVERNESS MEDICAL ACCUCLEAR EARLY PREGNANCY TEST  
K002049 Urine hCG By Visual Color Comparison Tests Endocrinology 03/05/2003
IND DIAGNOSTIC ONE STEP CASSETTE STYLE HCG URINE PREGNANCY TEST  
K023638 Urine hCG By Visual Color Comparison Tests Endocrinology 02/21/2003
IMMUNOSTICS IMMUNO/STREP A DETECTOR  
K010582 Streptococcus, Group A Bacteriology 02/13/2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM  
K023561 HGB, SINGLE ANALYTE INST. W/SELF-CONT... Hematology 02/12/2003
IMMUNOCARD STAT! HCG COMBO ADVANTAGE PREGNANCY TEST  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 11/13/2002
IND DIAGNOSTIC ONE STEP CASSETTE STYLE HCG SERUM/URINE COMBO TEST  
K974009 Urine hCG By Visual Color Comparison Tests Endocrinology 11/13/2002
INTERNATIONAL NEWTECH DEVELOP. MINISTRIP HCG ONESTEP  
K974059 Urine hCG By Visual Color Comparison Tests Endocrinology 09/25/2002
IMMUNOSTICS IMMUNO DETECTOR COMBI  
K013194 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
IMMUNOSTICS IMMUNO DETECTOR PERSONAL  
K960174 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
ITC PROTIME MICROCOAGULATION SYSTEM  (Prescription Home Use)
K010599 Prothrombin Time (PT) Hematology 07/23/2001
ITC PROTIME MICROCOAGULATION SYSTEM  (Professional Use)
K010599 Prothrombin Time (PT) Hematology 07/23/2001
IVERNESS MEDICAL TECHNOLOGY INDUO BLOOD GLUCOSE METER  
K011616 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/20/2001
ICON DS STREP A  
K010582 Streptococcus, Group A Bacteriology 07/17/2001
INTERNATIONAL NEWTECH DEVELOP. URINALYSIS REAGENT STRIP (10 PARAMETERS)  
K993850 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/05/2001
INVERNESS MEDICAL EARLY OVULATION PREDICTOR  (stick)
K002867 Luteinizing Hormone (LH) Endocrinology 10/23/2000
 
-
-
-
-
-