Identity
- Trade Name
- NOVEOS® Immunoassay System EUDAMEDNOVEOS FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- NOVEOS® Immunoassay System EUDAMEDThe NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory. FDA UDI
- Model / Reference
- 63000 EUDAMEDImmunoassay Analyzer FDA UDI
- Description
- The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory. FDA UDI
Identifiers
- Catalog Number
- 63000 FDA UDI
- Primary DI / UDI-DI
- 00816879022995 EUDAMEDFDA UDI
- Basic UDI-DI
- 081687902NOVINST37 EUDAMED
- 510(k) Number
- K182479 FDA UDI
- FDA Product Code
- JJE FDA UDIDHB FDA UDI
- EMDN Code
- W0201020102,W0201020192 EUDAMED
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 FDA UDI866.5750 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
The NOVEOS Immunoassay System is a cutting-edge medical device designed for accurate and reliable immunoassay testing. Developed by Hycor Biomedical LLC, this system offers high-quality results with minimal reagent usage.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081687902NOVINST37 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Hycor Biomedical LLC
- EUDAMED SRN
- US-MF-000031449
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 6d24fa54-ead8-44aa-878e-f92ba05841d8 61 fields · synced Jul 22, 2026
- FDA UDI 924cc5bb-e3bc-417f-8fa3-96ef2b0c556c 36 fields · synced May 30, 2026