VITROS ANTI-HBC IGM ASSAY
FDA premarket approval P030026/S030 · decided 2015-09-08
Approval details
- PMA number
- P030026
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS ANTI-HBC IGM ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2015-08-10
- Decision date
- 2015-09-08
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- CHANGE TO AN ENVIRONMENTALLY CONTROLLED ROOM USED FOR DISPENSING VITROS REAGENTS.
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