DIASORIN ETI-AB-EBK PLUS
FDA premarket approval P990041/S002 · decided 2002-11-08
Approval details
- PMA number
- P990041
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DIASORIN ETI-AB-EBK PLUS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2002-10-17
- Decision date
- 2002-11-08
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- CHANGE IN THE VENDOR OF THE BULK SOLUTION USED IN THE PREPARATION OF THE CHROMAGEN/SUBSTRATE KIT REAGENT WITH AN ACCOMPANYING CHANGE IN THE STOP SOLUTION CONCENTRATION.
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