Immco Diagnostics 1142
Immco Diagnostics 1142 is a Class II device made by Immco Diagnostics, Inc., listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00845714000126), registry data as of 23 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 | Number00845714000126 | Date21 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00845714000126
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Immco Diagnostics
- Generic name
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 1142
- Primary DI / UDI-DI
- 00845714000126
- FDA product code
- MOB
- GMDN term
- Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay.
- ANCA-L Test System 10140L-11 by IMMUNO CONCEPTS INC
- IFA: Granulocyte Mosaic 13 EUROPattern FC 1201-2450-13 by EUROIMMUN Medizinische Labordiagnostika AG
- IFA: Granulocytes (EOH) FA 1200-2005 by EUROIMMUN Medizinische Labordiagnostika AG
- Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed) A060L by ZEUS SCIENTIFIC, INC.
- Anti-Neutrophil Cytoplasmic Antibodies (Formalin-fixed) A060PL by ZEUS SCIENTIFIC, INC.
- NOVA Lite® ANCA Kit 708296 by Inova Diagnostics. Inc.