VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
FDA premarket approval P030026/S021 · decided 2011-04-22
Approval details
- PMA number
- P030026
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2010-12-08
- Decision date
- 2011-04-22
- Days to decision
- 135 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- A CHANGE IN THE MANUFACTURING SCALE OF A REAGENT COMPONENT.
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