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
Omnis Health Embrace No Code Blood Glucose Monitoring System  
K090043 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 09/01/2009
Ok Biotech Co., Ltd. Ok Meter Blood Glucose Monitoring System  
K063026 Glucose Monitoring Devices (FDA Cleared/Home Use) General Chemistry 02/13/2007
OcculTech Fecal Occult Blood Rapid Test  
K060953 Fecal Occult Blood General Chemistry 09/22/2006
ORASURE ORAQUICK ADVANCE RAPID HIV-1/2 ANTIBODY TEST  (ORAL FLUID, FINGERSTICK WHOLE BLOOD AND VENIPUNCTURE WHOLE BLOOD)
BP010047 HIV-1 and HIV-2 Antibodies General Immunology 06/25/2004
ORASURE TECHNOLOGIES ORAQUICK RAPID HIV-1 ANTIBODY TEST  (Fingerstick, Venipuncture Whole Blood)
BP010047 HIV-1 Antibody General Immunology 09/30/2003
ORASURE ORAQUICK RAPID HIV-1 TEST  
BP010047 HIV-1 Antibody General Immunology 01/31/2003
O2 UNLIMITED DONNA OVULATION TESTER  
K020811 Fern Test, Saliva Endocrinology 08/26/2002
OSTEX INTERNATIONAL OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE  
K011052 COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) Endocrinology 07/30/2001
 
-
-
-
-
-