DIASORIN ETI-HA-IGMK PLUS
FDA premarket approval P890014/S005 · decided 2003-05-06
Approval details
- PMA number
- P890014
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIASORIN ETI-HA-IGMK PLUS
- Generic name
- Hepatitis a test (antibody and igm antibody)
- Applicant
- DiaSorin, Inc.
- Date received
- 2003-04-14
- Decision date
- 2003-05-06
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LOL
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- CHANGE IN THE QUANTITY OF NON-SPECIFIC MOUSE IGG USED IN THE PREPARATION OF THE SAMPLE DILUENT, POSITIVE CONTROL AND NEGATIVE CONTROL KIT REAGENTS OF THE DIASORIN ETI-HA-IGMK PLUS.
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