Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
FDA premarket approval P100001/S013 · decided 2018-02-16
Approval details
- PMA number
- P100001
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vitros Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics
- Date received
- 2018-01-25
- Decision date
- 2018-02-16
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Add an additional supplier and introduce a processing step to the manufacturing of plasma.
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