Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
FDA product code LGR · 15 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3350
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1984-05-22 – 1996-03-11
LGR
1996-03-11
LGR
1996-01-24
INNOFLUOR PHENYTOIN ASSAY SYSTEM
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LGR
1995-09-25
AXSYM PHENYTOIN II
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LGR
1995-03-28
TDX(R)/TDXFLX(R) PHENYTOIN II
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LGR
1994-10-27
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS
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LGR
1994-06-21
AXSYM PHENYTOIN ASSAY
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LGR
1994-03-11
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
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LGR
1990-01-02
OPUS PHENYTOIN TEST SYSTEM
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LGR
1989-10-31
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET
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LGR
1987-08-21
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
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LGR
1986-07-16
IMMPULSE PHENYTOIN ASSAY REAGENT
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LGR
1985-02-01
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
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LGR
1984-12-10
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE
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LGR
1984-09-26
PHENYTOIN KIT FLUORESCENCE POLARIZATION
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LGR
1984-05-22
INNOFLUOR PHENYTOIN
View details →No matching devices.
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