Identity
- Trade Name
- cobas® TaqScreen WNV Test FDA UDI
- Generic Name
- West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 04741722190 FDA UDI
Identifiers
- Catalog Number
- 04741722190 FDA UDI
- Primary DI / UDI-DI
- 00875197001846 FDA UDI
- GMDN Term
- West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
cobas® TaqScreen WNV Test by Roche Molecular Systems, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT).
- Procleix WNV Assay — Grifols Diagnostic Solutions Inc.
- cobas® WNV (96 tests) — Roche Diagnostics Corp.
- Procleix WNV Assay — Grifols Diagnostic Solutions Inc.
- Procleix WNV Assay — Grifols Diagnostic Solutions Inc.
- Procleix WNV Assay — Grifols Diagnostic Solutions Inc.
- Procleix WNV Assay — Grifols Diagnostic Solutions Inc.
- Procleix WNV Assay — Grifols Diagnostic Solutions Inc.
- cobas® WNV (480 tests) — Roche Diagnostics Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA UDI 3e77d339-0916-4ef4-b381-3d14530a304e 33 fields · synced Jun 9, 2026