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CLIA - Tests waived by FDA from January 2000 to present

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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.
 
 
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Show All Test Systems Download Files | More About CLIA
Document Test System Name
Analyte		 Analyte Specialty Effective Date
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Ketone Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Bilirubin Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Blood Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Glucose Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Leukocytes Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Nitrite Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick pH Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Protein Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Urobilinogen Urinalysis 10/28/2009
Diagnostic Test Group Clarity Urocheck 120 Urine Analyzer  
K070929 Urine Qualitative Dipstick Specific Gravity Urinalysis 10/28/2009
Diagnostic Test Group, Clarity Plus Blood Glucose Monitoring System  
K090057 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 08/07/2009
Diagnostic Devices Prodigy AutoCode Talking Blood Glucose Monitoring System  
K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009
Diagnostic Devices Prodigy Pocket Blood Glucose Monitoring System  
K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009
Diagnostic Devices Prodigy Voice Talking Blood Glucose Monitoring System  
K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/08/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 10 SG Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/09/2009
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11 SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 11SG Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 4 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 7 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 8 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Bilirubin Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick pH Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck 9 Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/21/2008
Diagnostic Test Group Clarity Urocheck Blood Urine Reagent Strips for Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 11/21/2008
Diagnostic Test Group Clarity Ketone Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Ketone Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 2 GP Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Blood Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Glucose Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Leukocytes Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Nitrite Urinalysis 05/19/2008
Diagnostic Test Group Clarity Urocheck 5 OB Urine Reagent Strips For Urinalysis  
K061559 Urine Qualitative Dipstick Protein Urinalysis 05/19/2008
Diagnostic Test Group Clarity Strep A Rapid Test Strips  
K983386 Streptococcus, Group A Bacteriology 04/08/2008
Diagnostic Devices Prodigy Voice Blood Glucose Monitoring System  
K073118 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2008
Diagnostic Test Group, Clarity Blood Glucose Monitoring System  
K062829 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 03/12/2008
Diagnostic Test Group Clarity H. pylori Rapid Test Device  (Whole Blood)
K980798 Helicobacter Pylori Antibodies General Immunology 01/22/2008
Diagnostic Devices, Inc. Prodigy Autocode Blood Glucose Monitoring System  
K072784 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 01/08/2008
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Ketone Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Bilirubin Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Glucose Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Nitrite Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Blood Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Leukocytes Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick pH Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Protein Urinalysis 11/16/2007
Diagnostic Test Group Clarity Urocheck 10SG Urine Reagent Strips for Urinalysis  
K052719 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/16/2007
Duramed Pharmaceuticals, Inc. AmniScreen Home Detection Liner Kit  
K071100 Vaginal pH General Chemistry 10/15/2007
Diacare Corp. EASY CHECK Blood Glucose Monitoring System  
K062538 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 05/02/2007
Diabetic Supply of Suncoast, Inc. Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System  
K070641 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 04/12/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Ketone Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Bilirubin Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Blood Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Glucose Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Leukocytes Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Nitrite Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick pH Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Protein Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Urobilinogen Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Specific Gravity Urinalysis 02/07/2007
Diagnostic Test Group Clarity Urocheck 11 Urine Reagent Strips for Urinalysis  
K023885 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 02/07/2007
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Amphetamines Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Cannabinoids (THC) Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Phencyclidine (PCP) Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Cocaine Metabolites Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Opiates Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Methamphetamines Toxicology / TDM 12/28/2006
Drug Detection Devices Ltd. Multi-Drug Multi-Line Screeners Dip Drug Test With the Integrated Screeners AutoSplit KO Test Cup  
K050878 Methylenedioxymethamphetamine (MDMA) Toxicology / TDM 12/28/2006
Diagnostic Devices Prodigy Blood Glucose Test System  
K060467 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/27/2006
Diagnostic Devices, Inc. Prodigy Blood Glucose Monitoring System  
K053593 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 07/07/2006
Diagnostic Test Group, Clarity Blood Glucose Monitoring System  
K051854 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 06/15/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Ketone Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Bilirubin Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Blood Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Glucose Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Nitrite Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick pH Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Protein Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Specific Gravity Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis  
K052525 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   
K052525 Urine Qualitative Dipstick Leukocytes Urinalysis 04/11/2006
DFI Co., LTD. CYBOW 11 Reagent test strips for Urinalysis   
K052525 Urine Qualitative Dipstick Urobilinogen Urinalysis 04/11/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Ketone Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Bilirubin Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Blood Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Glucose Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Leukocytes Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Nitrite Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick pH Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Protein Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Urobilinogen Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Specific Gravity Urinalysis 01/24/2006
DE Healthcare Products Ultrascreen 10+SG  
K991927 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 01/24/2006
DE Healthcare Products TruView hCG Pregnancy Test  
K954444 Urine hCG By Visual Color Comparison Tests Endocrinology 02/18/2005
DE Healthcare Products TruView hCG Combo Pregnancy Cassette Test  
K992187 Urine hCG By Visual Color Comparison Tests Endocrinology 02/17/2005
DE Healthcare Products TruView hCG Pregnancy Cassette Test  
K953988 Urine hCG By Visual Color Comparison Tests Endocrinology 02/17/2005
DIAGNOSTIC DEVICES INC. GLUCOCHECK BLOOD GLUCOSE MONITORING SYSTEM  
K032029 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/01/2005
DYNAMIC DIAGNOSTICS INC. ONEPLUS PREGNANCY  
K981165 Urine hCG By Visual Color Comparison Tests Endocrinology 12/29/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ketone Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Bilirubin Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Blood Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Glucose Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Leukocytes Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Nitrite Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick pH Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Protein Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Urobilinogen Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Specific Gravity Urinalysis 11/17/2004
DIRUI URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS  (Manual - Qualitative)
K040703 Urine Qualitative Dipstick Ascorbic Acid Urinalysis 11/17/2004
DE HEALTHCARE PRODUCTS TRUVIEW H. PYLORI TEST  
K990892 Helicobacter Pylori Antibodies General Immunology 10/29/2004
DE HEALTHCARE PRODUCTS TRUVIEW STREP A DIPSTICK TEST  
K033855 Streptococcus, Group A Bacteriology 10/29/2004
DE HEALTHCARE PRODUCTS TRUVIEW STREP A TEST  
K023766 Streptococcus, Group A Bacteriology 04/15/2004
DE HEALTHCARE PRODUCTS TRU VIEW ONE-STEP PREGNANCY TEST  
K990578 Urine hCG By Visual Color Comparison Tests Endocrinology 11/19/2002
DE HEALTHCARE PRODUCTS TRUVIEW STREP A TEST  
K992658 Streptococcus, Group A Bacteriology 10/23/2002
DIAGNOSTIC CHEMICALS IMMUNODIP URINARY ALBUMIN TEST  
K022538 Albumin, Urinary General Chemistry 08/29/2002
DE HEALTHCARE PRODUCTS HCG STRIP TEST  
K941090 Urine hCG By Visual Color Comparison Tests Endocrinology 06/12/2002
DE HEALTHCARE PRODUCTS DETECT~OCCULT SLIDE TEST FOR FECAL OCCULT BLOOD  
K902360 Fecal Occult Blood General Chemistry 04/05/2002
DIAGNOSTIC CHEMICALS IMMUNODIP URINARY ALBUMIN SCREEN  
K994035 Microalbumin General Chemistry 08/29/2001
DIAGNOSTICA, INC. EASE-A-CULT SENSITIVE  
K002756 Fecal Occult Blood General Chemistry 02/21/2001
DISCOUNT DRUG MART FOOD FAIR BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
DRUG EMPORIUM BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
DUANE READE BLOOD GLUCOSE SYSTEM  
K992988 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 12/13/2000
 
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