PMA P190033S001

Device: AAV5 DetectCDx®
Applicant: ARUP Laboratories
PMA number: P190033
Supplement: S001
Product code: QWQ
Decision date: 2024-10-04
Classification: Hematology
Generic name: Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
Approval order statement: To change the scale of size exclusion chromatography, and accept SULFO-TAG AAV5 Capsid below previously-defined method acceptance criteria.

Current openFDA PMA Record#

Device: AAV5 DetectCDx®
Applicant: ARUP Laboratories
PMA number: P190033
Supplement: S001
Product code: QWQ
Generic name: Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
Decision date: 2024-10-04
Decision code: OK30
Date received: 2024-09-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: To change the scale of size exclusion chromatography, and accept SULFO-TAG AAV5 Capsid below previously-defined method acceptance criteria.