VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG
FDA premarket approval P090028/S006 · decided 2012-12-21
Approval details
- PMA number
- P090028
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ABEAG
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2012-11-29
- Decision date
- 2012-12-21
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- CHANGE TO THE LIMITS OF AN IN-PROCESS TEST USED IN THE ASSESSMENT OF STREPTAVIDIN COATED WELLS, A COMPONENT OF THE DEVICE.
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