DIASORIN ETI-AB-COREK PLUS ASSAY
FDA premarket approval P990045/S005 · decided 2003-11-26
Approval details
- PMA number
- P990045
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DIASORIN ETI-AB-COREK PLUS ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2003-10-20
- Decision date
- 2003-11-26
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- APPROVAL FOR EXTENSION OF THE ETI-AB-COREK PLUS ASSAY EXPIRATION DATING FROM 7 MONTHS AND A MINOR LABELING CHANGE IN THE ANALYTICAL SENSITIVITY SECTION OF THE PACKAGE INSERT TO CORRECT A CALCULATION ERROR.
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