ETI-AB-AUK PLUS assay
FDA premarket approval P990042/S020 · decided 2017-10-16
Approval details
- PMA number
- P990042
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETI-AB-AUK PLUS assay
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- DiaSorin, Inc.
- Date received
- 2017-09-18
- Decision date
- 2017-10-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Stillwater, MN
- Statement
- Relocation of manufacturing activities related to incoming components.
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|---|---|---|
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| LIAISON Ferritin (K193650) | DiaSorin, Inc. | 2021-09-14 |
| LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (K202573) | DiaSorin, Inc. | 2021-02-18 |