Immco Diagnostics 2107X
Immco Diagnostics 2107X is a medical device (FDA Class II; FDA product code MVM, Autoantibodies, Endomysial(Tissue Transglutaminase)) made by Immco Diagnostics, Inc., cleared under FDA 510(k) K060157 on 25 May 2006 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00845714003035), 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 | Number00845714003035 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK060157 | Date25 May 2006 | StatusActive |
Official records
- AccessGUDID record 00845714003035
- FDA 510(k) database K060157
Across registries
- FDA 510(k) K060157 decided 25 May 2006 Active
- FDA GUDID UDI-DI 00845714003035 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K060157
- Listed FDA GUDID 00845714003035
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Immco Diagnostics
- Generic name
- Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
- Model / Ref / Catalog
- 2107X
- Primary DI / UDI-DI
- 00845714003035
- 510(k) Number
- FDA product code
- MVM
- GMDN term
- Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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