DIASORIN ETI-MAK-2 PLUS
FDA premarket approval P990038/S008 · decided 2004-05-19
Approval details
- PMA number
- P990038
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIASORIN ETI-MAK-2 PLUS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2004-04-23
- Decision date
- 2004-05-19
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- CHANGE IN THE MANUFACTURING MATERIALS USED TO PRODUCE THE ETI-MAK-2 PLUS TRACER DILUENT. THIS CHANGE WAS TO ADD INACTIVATED HORSERADISH PEROXIDASE, 2.5 MG/L, TO THE ETI-MAK-2 PLUS TRACER DILUENT.
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