Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA product code LTK · 24 cleared devices
Class 2
Immunology
- Regulation
- 21 CFR 866.6010
- Review panel
- IM
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1997-10-31 – 2024-05-10
LTK
2024-05-10
LTK
2023-09-08
IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
View details →
LTK
2022-12-12
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
View details →
LTK
2020-04-06
ADVIA Centaur CA 125II
View details →
LTK
2011-04-12
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
View details →
LTK
2009-06-22
VIDAS CA 15-3 ASSAY
View details →
LTK
2009-04-10
VIDAS CA 125 II ASSAY
View details →
LTK
2007-11-05
IMMULITE 2500 OM-MA, MODEL L5KOP
View details →
LTK
2004-11-19
ARCHITECT CA 125 II ASSAY
View details →
LTK
2003-05-02
ACCESS OV MONITOR ASSAY
View details →
LTK
2002-12-11
ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
View details →
LTK
2002-12-06
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
View details →
LTK
2002-11-27
CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
View details →
LTK
2002-07-24
CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
View details →
LTK
1999-06-03
AIA-PACK CA 125
View details →
LTK
1999-05-14
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II REAGENT PACK
View details →
LTK
1999-05-14
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
View details →
LTK
1998-10-15
IMMULITE 2000 OM-MA MODEL L2KOP2
View details →
LTK
1998-09-18
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
View details →
LTK
1998-03-25
ELECSYS CA 125II ON THE ELECSYS 1010
View details →
LTK
1998-03-18
ELECSYS CA 125 II
View details →
LTK
1997-11-04
IMX CA 125
View details →
LTK
1997-11-04
AXSYM CA 125
View details →
LTK
1997-10-31
CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
View details →No matching devices.
Advertisement