ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP
FDA premarket approval P930036/S020 · decided 2022-09-30
Approval details
- PMA number
- P930036
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP
- Generic name
- KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2022-09-01
- Decision date
- 2022-09-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOK
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Manufacturing process change to the affinity purification method used to purify the anti-AFP polyclonal antibodies (Lite Reagent).
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|---|---|---|
| Atellica CH Acetaminophen 2 (ACTM) (K261364) | Siemens Healthcare Diagnostics, Inc. | 2026-07-24 |
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