Identity
- Trade Name
- hc2 High-Risk HPV DNA Test FDA UDI
- Generic Name
- Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- digene® HC2 High-Risk HPV DNA Test (1-Plate Kit) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- digene® HC2 High-Risk HPV DNA Test (1-Plate Kit) FDA UDI
Identifiers
- Catalog Number
- 5199-1220 FDA UDI
- Primary DI / UDI-DI
- 04053228002031 FDA UDI
- PMA Number
- P890064 FDA UDI
- FDA Product Code
- MAQ FDA UDI
- GMDN Term
- Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class III 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
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: Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA)
hc2 High-Risk HPV DNA Test by QIAGEN Sciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human papillomavirus (HPV) antigen IVD, kit, enzyme immunoassay (EIA).
- hc2 HPV DNA Test — QIAGEN Sciences LLC · Class III
- hc2 High-Risk HPV DNA Test — QIAGEN Sciences LLC · Class III
Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- QIAGEN Sciences LLC
Sources (1)
- FDA UDI 9f9aba8d-cf31-4d77-bc55-b46515410cd6 35 fields · synced May 31, 2026