Fluorescent ANA Test System 500
Ref 500
Fluorescent ANA Test System 500 is a device classified as IVD General made by Immuno Concepts Inc, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI B-M7490005001) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI M7490005001), active as of 24 Oct 2026.
Active
CE IVDD
Valid until
No date given
FDA recalls
Not checked
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD EUDAMED | NumberB-M7490005001 M7490005001 | Date7 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | NumberM7490005001 | Date24 Sep 2016 | StatusListed |
Official records
- EUDAMED public site B-M7490005001
Across registries
- EUDAMED Basic UDI-DI B-M7490005001 registered 7 Sep 2026 Active
- FDA GUDID UDI-DI M7490005001 listed 24 Sep 2016 Listed
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Timeline
- Listed FDA GUDID M7490005001
- Registered EUDAMED B-M7490005001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- ANA Fluorescent Test System EUDAMEDFluorescent ANA Test System GUDID
- Generic name
- Multiple thyroid antibody IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 500
- Primary DI / UDI-DI
- M7490005001
- Basic UDI-DI
- B-M7490005001
- EMDN code
- W01029099 Immunochemistry reagents - other
- GMDN term
- Multiple thyroid antibody IVD, kit, fluorescent immunoassay
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
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