Orfit Industries 32428
Orfit Industries 32428 is a Class II device made by Orfit Industries NV, cleared under FDA 510(k) K991319 on 21 Sep 1999 and listed in FDA GUDID since 7 Dec 2022 (UDI-DI 05420028754627), active as of 23 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 | Number05420028754627 | Date7 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991319 | Date21 Sep 1999 | StatusActive |
Official records
- AccessGUDID record 05420028754627
- FDA 510(k) database K991319
Across registries
- FDA 510(k) K991319 decided 21 Sep 1999 Active
- FDA GUDID UDI-DI 05420028754627 listed 7 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K991319
- Listed FDA GUDID 05420028754627
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Orfit Industries
- Generic name
- DNA-based tissue typing IVD, reagent
- Model / reference
- 32428
- Primary DI / UDI-DI
- 05420028754627
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- DNA-based tissue typing IVD, reagent
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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