DIASORIN ETI-AB-EBK PLUS
FDA premarket approval P990041/S005 · decided 2004-03-26
Approval details
- PMA number
- P990041
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Trade name
- DIASORIN ETI-AB-EBK PLUS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2004-03-11
- Decision date
- 2004-03-26
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- CHANGE IN THE QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL USED IN THE PREPARATION OF COATED STRIPS OF THE ETI-AB-EBK PLUS WHICH IS AN IN VITRO ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B E ANTIGEN IN HUMAN SERUM OR PLASMA.
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