ETI-CORE-IGMK PLUS ASSAY
FDA premarket approval P990044/S014 · decided 2012-11-30
Approval details
- PMA number
- P990044
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETI-CORE-IGMK PLUS ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2012-11-09
- Decision date
- 2012-11-30
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR A CHANGE TO IMPROVE THE SAMPLING PLAN IN THE QUALITY CONTROL METHOD FOR THE INCOMING RAW MATERIAL MICROWELL PLATES.
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