P STR Pack 4 WELL 5801
P STR Pack 4 WELL 5801 is a Class II device made by Scimedx Corp., listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00813545020613), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00813545020613 | Date16 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00813545020613
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- P STR Pack 4 WELL
- Generic name
- Striated muscle antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 5801
- Primary DI / UDI-DI
- 00813545020613
- FDA product code
- DBL
- GMDN term
- Striated muscle antibody IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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