VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT
FDA premarket approval P000044/S013 · decided 2006-07-14
Approval details
- PMA number
- P000044
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITROS IMMUNODIAGNOSTIC HBSAG REAGENT PACK CALIBRATOR AND CONFIRMATORY KIT
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2006-05-25
- Decision date
- 2006-07-14
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR REMOVAL OF A WARNING REGARDING ASSAY PERFORMANCE CHARACTERISTICS WITH NEONATES.
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