Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA product code LOJ · 17 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
- 1985-07-19 – 2022-09-15
LOJ
2022-09-15
LOJ
2022-06-15
VITROS AFP
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LOJ
2009-04-27
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
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LOJ
2009-03-16
OLYMPUS AFP - ALPHA-FETOPROTEIN
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LOJ
2008-09-26
VIDAS AFP ASSAY
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LOJ
2008-06-04
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
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LOJ
2002-12-17
ST AIA-PACK AFP ENZYME IMMUNOASSAY
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LOJ
2002-10-01
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
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LOJ
2002-03-27
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
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LOJ
1999-06-21
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
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LOJ
1998-12-18
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
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LOJ
1998-12-07
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
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LOJ
1998-05-01
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
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LOJ
1998-05-01
ELECSYS AFP
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LOJ
1997-11-21
ELECSYS AFP
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LOJ
1997-09-22
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
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LOJ
1985-07-19
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
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