ETI-CORE-IGMK PLUS ASSAY
FDA premarket approval P990044/S009 · decided 2010-01-12
Approval details
- PMA number
- P990044
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ETI-CORE-IGMK PLUS ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2009-11-13
- Decision date
- 2010-01-12
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO8 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE.
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