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FREND™ COVID-19 total Ab
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref FRCOA 020Model FREND™ COVID-19 total Ab
Identity
- Trade Name
- FREND™ COVID-19 total Ab EUDAMEDFREND COVID-19 total Ab FDA UDI
- Generic Name
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- FRCOA 020 EUDAMEDThe COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System. FDA UDI
- Model / Reference
- FREND™ COVID-19 total Ab EUDAMEDFRCOA 020 EUDAMEDFREND COVID-19 total Ab FDA UDI
- Description
- The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System. FDA UDI
Identifiers
- Catalog Number
- FRCOA 020 FDA UDI
- Primary DI / UDI-DI
- 08809317540924 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540924 EUDAMED
- FDA Product Code
- QKO FDA UDI
- EMDN Code
- W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
- GMDN Term
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDN FDA UDI
- Market of Registration
- Germany 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FREND™ COVID-19 total Ab by NanoEnTek, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08809317540924 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED a9a934c7-b17c-4eb8-afee-2e9f57ec5d97 61 fields · synced Jun 18, 2026
- FDA UDI c7391c5c-935a-44cf-a430-61bb3653edaa 34 fields · synced May 30, 2026
- EUDAMED e04c0cd6-bf30-4cd9-8bcb-d73a41b26dfb 61 fields · synced Jun 18, 2026