PR3 IgG Test System PR3396
PR3 IgG Test System PR3396 is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K954105 on 19 Mar 1996 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 00813545029043), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813545029043 | Date13 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK954105 | Date19 Mar 1996 | StatusActive |
Official records
- AccessGUDID record 00813545029043
- FDA 510(k) database K954105
Across registries
- FDA 510(k) K954105 decided 19 Mar 1996 Active
- FDA GUDID UDI-DI 00813545029043 listed 13 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K954105
- Listed FDA GUDID 00813545029043
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PR3 IgG Test System
- Generic name
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- PR3396
- Primary DI / UDI-DI
- 00813545029043
- 510(k) Number
- FDA product code
- MOB
- GMDN term
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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