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COVID-19 total Ab Control LQ
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref FIC-COALQModel COVID-19 total Ab Control LQ
Identity
- Trade Name
- COVID-19 total Ab Control LQ EUDAMEDFDA UDI
- Generic Name
- SARS-CoV-2 total antibody IVD, control FDA UDI
- Device Name
- FIC-COALQ EUDAMEDThe COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard. FDA UDI
- Model / Reference
- COVID-19 total Ab Control LQ EUDAMEDFIC-COALQ EUDAMEDFDA UDI
- Description
- The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard. FDA UDI
Identifiers
- Catalog Number
- FIC-COALQ FDA UDI
- Primary DI / UDI-DI
- 08809317540917 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540917 EUDAMED
- FDA Product Code
- QKO FDA UDI
- EMDN Code
- W0105040619 EUDAMED
- GMDN Term
- SARS-CoV-2 total antibody IVD, control 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
No
EUDAMED
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
COVID-19 total Ab Control LQ 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-08809317540917 | 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 (2)
- EUDAMED e6e8cdd9-b7ec-42f0-8fe3-6b33b5a101ff 61 fields · synced Jun 18, 2026
- FDA UDI 5d6bc5c0-6896-42db-bbfd-103a3ab95a07 34 fields · synced May 29, 2026