IMMUNO CONCEPTS Test Systems 1012 (20)
Ref 1012 (20)
IMMUNO CONCEPTS Test Systems 1012 (20) is a pH-adjusted buffer solution IVD (EU IVDD general IVD) made by Immuno Concepts Inc, registered in EUDAMED on 7 Sep 2026 (Basic UDI-DI B-M7491012201) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI M7491012201), active as of 25 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-M7491012201 M7491012201 | Date7 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | NumberM7491012201 | Date24 Sep 2016 | StatusListed |
Official records
- EUDAMED public site B-M7491012201
Across registries
- EUDAMED Basic UDI-DI B-M7491012201 registered 7 Sep 2026 Active
- FDA GUDID UDI-DI M7491012201 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 M7491012201
- Registered EUDAMED B-M7491012201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- ANA Fluorescent Test System EUDAMEDIMMUNO CONCEPTS Test Systems GUDID
- Generic name
- pH-adjusted buffer solution IVD
- Model / Ref / Catalog
- 1012 (20)
- Primary DI / UDI-DI
- M7491012201
- Basic UDI-DI
- B-M7491012201
- EMDN code
- W01029099 Immunochemistry reagents - other
- GMDN term
- pH-adjusted buffer solution IVD
- Device class
- Class IVD General
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under IMMUNOCHEMISTRY REAGENTS - OTHER.
- Glial fibrillary acidic protein (GFAP) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA) by JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
- Substrate Solution 105-048065-00 by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Secondary reagents immunoblot (IgM) ZD 1129-0101-1 M by EUROIMMUN Medizinische Labordiagnostika AG
- Epitope Retrieval Solution by Guangzhou LBP Medicine Science & Technology Co.,Ltd.
- Krebs von den Lungen-6 (KL-6) Quantitative Test Kit (Chemiluminescent Immunoassay, CLIA) by JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD
- Access CEA Diluent 33206 by Beckman Coulter, Inc.
- Immunochromogenic Reagent 600 Tests by Xiamen Talent Biomedical Technology Co.,Ltd
- LIAISON® 1-84 PTH Specimen Diluent 310632 by Diasorin Inc.
- ELISA chromogen/substrate solution ZE 1200-1012 by EUROIMMUN Medizinische Labordiagnostika AG
- Plasmin-Alpha 2 Plasmin Inhibitor Complex Chemiluminescence Immunoassay Kit S2048E-200 by Sansure Biotech Inc.