AAV5 DetectCDx®
FDA premarket approval P190033/S001 · decided 2024-10-04
Approval details
- PMA number
- P190033
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AAV5 DetectCDx®
- Generic name
- Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
- Applicant
- ARUP Laboratories
- Date received
- 2024-09-05
- Decision date
- 2024-10-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QWQ
- Advisory committee
- Hematology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- To change the scale of size exclusion chromatography, and accept SULFO-TAG AAV5 Capsid below previously-defined method acceptance criteria.
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