MeDiCa 0604-ESD
MeDiCa 0604-ESD is a Class II device made by Scimedx Corp., cleared under FDA 510(k) K993034 on 1 Nov 1999 and listed in FDA GUDID since 1 Dec 2020 (UDI-DI 00813545026707), 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 | Number00813545026707 | Date1 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993034 | Date1 Nov 1999 | StatusActive |
Official records
- AccessGUDID record 00813545026707
- FDA 510(k) database K993034
Across registries
- FDA 510(k) K993034 decided 1 Nov 1999 Active
- FDA GUDID UDI-DI 00813545026707 listed 1 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K993034
- Listed FDA GUDID 00813545026707
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MeDiCa
- Generic name
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 0604-ESD
- Primary DI / UDI-DI
- 00813545026707
- 510(k) Number
- FDA product code
- MVM
- GMDN term
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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- Histofluor® Primate Esophagus Autoantibody Fluorescent Test System 12008-01 (10) by IMMUNO CONCEPTS INC
- IFA: Oesophagus (Monkey) IgA FA 1911-1005 A by EUROIMMUN Medizinische Labordiagnostika AG