Immco Diagnostics 5162
Immco Diagnostics 5162 is a Class II device made by Immco Diagnostics, Inc., listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00845714002359), 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 | Number00845714002359 | Date21 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00845714002359
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Immco Diagnostics
- Generic name
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 5162
- Primary DI / UDI-DI
- 00845714002359
- FDA product code
- MOB
- GMDN term
- Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.5660
- GUDID distribution status
- In Commercial Distribution
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