MeDiCa 0201
MeDiCa 0201 is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K790106 on 15 Mar 1979 and listed in FDA GUDID since 1 Dec 2020 (UDI-DI 00813545026585), 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 | Number00813545026585 | Date1 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK790106 | Date15 Mar 1979 | StatusActive |
Official records
- AccessGUDID record 00813545026585
- FDA 510(k) database K790106
Across registries
- FDA 510(k) K790106 decided 15 Mar 1979 Active
- FDA GUDID UDI-DI 00813545026585 listed 1 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K790106
- Listed FDA GUDID 00813545026585
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MeDiCa
- Generic name
- Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 0201
- Primary DI / UDI-DI
- 00813545026585
- 510(k) Number
- FDA product code
- DHC
- GMDN term
- Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5820
- GUDID distribution status
- In Commercial Distribution
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