QUANTITOPE 125I AFP KIT AND CONTROL SERUM
FDA premarket approval P800025/S005 · decided 1996-10-02
Approval details
- PMA number
- P800025
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUANTITOPE 125I AFP KIT AND CONTROL SERUM
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Bio-Rad Laboratories, Inc.
- Date received
- 1995-12-21
- Decision date
- 1996-10-02
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Marnes-La-Coquette
- Statement
- REPLACEMENT OF THE CURRENT RADIOLABELED AFP WITH A NEW AFP ANTIGEN
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