VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS
FDA premarket approval P000014/S002 · decided 2001-08-29
Approval details
- PMA number
- P000014
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2001-03-12
- Decision date
- 2001-08-29
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL TO CHANGE THE TEST RELEASE LIMITS APPLIED TO THE OUTPUT OF THAT MODEL FOR THE VITROS ANTI-HBS ASSAY.
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