Enzyme Immunoassay, Procainamide
FDA product code LAR · 25 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3320
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1978-10-17 – 2006-08-23
LAR
2006-08-23
LAR
2003-10-31
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
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LAR
2001-04-13
EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
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LAR
1997-06-27
PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
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LAR
1996-10-29
CEDIA N-ACETYLPROCAINAMIDE ASSAY
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LAR
1996-08-27
CEDIA PROCAINAMIDE ASSAY
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LAR
1996-08-14
PROCAINAMIDE ENZYME IMMUNOASSAY
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LAR
1996-04-02
ABBOTT AXSM PROCAINAMIDE ASSAY
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LAR
1995-07-03
OPUS PROCAINAMIDE
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LAR
1994-12-02
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
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LAR
1994-07-20
OPUS PROCAINAMIDE TEST SYSTEM
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LAR
1992-08-24
EMIT 2000 PROCAINAMIDE CALIBRATORS
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LAR
1987-09-29
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
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LAR
1986-02-11
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
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LAR
1985-07-09
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
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LAR
1985-04-12
EMIT QST PROCAINAMIDE ASSAY
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LAR
1984-02-03
TDX PROCAINAMIDE
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LAR
1983-12-27
PROCAINAMIDE ANALYTICAL TEST PACK
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LAR
1983-09-12
EMIT CAD PROCAINAMIDE ASSAY
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LAR
1983-06-02
AMES TDA PROCAINAMIDE TEST
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LAR
1982-11-29
ADVANCE EMIT CAD PROCAINAMIDE ASSAY
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LAR
1981-07-10
EMIT-CAD PROCAINAMIDE ASSAY
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LAR
1981-05-01
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY
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LAR
1979-03-21
EMIT QUINIDINE ASSAY
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LAR
1978-10-17
EMIT PROCAINAMIDE ASSAY
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