Identity
- Trade Name
- artus® HSV-1/2 QS-RGQ MDx Kit FDA UDI
- Generic Name
- Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 4526346 FDA UDI
- Primary DI / UDI-DI
- 04053228004660 FDA UDI
- FDA Product Code
- OQO FDA UDI
- GMDN Term
- Multiple Human herpesvirus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3305 FDA UDI
- Commercial Distribution
- Not 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
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
artus® HSV-1/2 QS-RGQ MDx Kit by Qiagen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA UDI 3d09d998-2169-4f53-91af-72091e6236dc 34 fields · synced May 31, 2026