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RIDASCREEN® Norovirus 3rd Generation
EUDAMEDFDA UDIClass B (EU MDR)
Ref C1401Ref CRP1404
Identity
- Trade Name
- RIDASCREEN® Norovirus 3rd Generation FDA UDI
- Generic Name
- Norovirus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- RIDASCREEN® Norovirus 3rd Generation EUDAMEDThe RIDASCREEN® Norovirus 3rd Generation EIA test is a qualitative enzyme immunoassay (EIA) intended for the detection of selected genogroup I (GI.1, GI.2, GI.3, GI.4, GI.7) and genogroup II (GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.10, GII.12, GII.13, GII.14, GII.17) norovirus strains in human feces as an aid in investigating the cause of acute gastroenteritis outbreaks. FDA UDI
- Model / Reference
- C1401 EUDAMEDCRP1404 EUDAMEDC1401US FDA UDI
- Description
- The RIDASCREEN® Norovirus 3rd Generation EIA test is a qualitative enzyme immunoassay (EIA) intended for the detection of selected genogroup I (GI.1, GI.2, GI.3, GI.4, GI.7) and genogroup II (GII.1, GII.2, GII.3, GII.4, GII.5, GII.6, GII.7, GII.8, GII.10, GII.12, GII.13, GII.14, GII.17) norovirus strains in human feces as an aid in investigating the cause of acute gastroenteritis outbreaks. FDA UDI
Identifiers
- Catalog Number
- C1401US FDA UDI
- Primary DI / UDI-DI
- 04049095030079 EUDAMEDFDA UDI04049095030222 EUDAMED
- Basic UDI-DI
- 4049095C140100000HU EUDAMED
- 510(k) Number
- DEN110001 FDA UDI
- FDA Product Code
- OUC FDA UDI
- EMDN Code
- W0105040616 NOROVIRUS EUDAMED
- GMDN Term
- Norovirus antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3395 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
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Prescription Use
No
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
RIDASCREEN® Norovirus 3rd Generation by R-Biopharm AG — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 4049095C140100000HU | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- R-Biopharm AG
- EUDAMED SRN
- DE-MF-000007993
Sources (3)
- EUDAMED 41a30c85-2294-4c4a-8da7-eeac52136416 61 fields · synced Oct 6, 2026
- EUDAMED afe2ca10-01ab-4aec-a4b1-31039e22aba0 61 fields · synced May 18, 2026
- FDA UDI 0c0fb252-ac39-4c74-a009-b9f3ce105fe4 35 fields · synced May 30, 2026