Identity
- Trade Name
- HSV-2 Probe ASR FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 1066160 FDA UDI
- Primary DI / UDI-DI
- 04053228004370 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent
HSV-2 Probe ASR by Qiagen, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, reagent.
- MultiCode® HSV Primers — Luminex Corporation · Class I
- HSV-1 Probe ASR — Qiagen, Inc. · Class I
- HSV Primer ASR — Qiagen, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Qiagen, Inc.
Sources (1)
- FDA UDI 6c06764f-c40a-4aa2-ae8b-32ea29c67708 33 fields · synced May 30, 2026