VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT
FDA premarket approval P000044/S002 · decided 2001-06-18
Approval details
- PMA number
- P000044
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK, CALIBRATORS, AND CONFIRMATORY KIT
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2001-05-29
- Decision date
- 2001-06-18
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- CHANGE TO THE ACCEPTANCE CRITERIA APPLIED TO THE TEST FOR HUMAN PLASMA USED AS A RAW MATERIAL IN THE FORMULATION OF ASSAY REAGENT, A COMPONENT OF THE VITROS HBSAG REAGENT PACK AND IN THE FORMULATION OF SAMPLE DILUENT, A COMPONENT OF THE VITROS HBASAG CONFIRMATORY KIT.
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