Identity
- Trade Name
- digene® HC2 CT/GC DNA Test FDA UDI
- Generic Name
- Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 2 FDA UDI
Identifiers
- Catalog Number
- 5130-1220 FDA UDI
- Primary DI / UDI-DI
- 04053228010265 FDA UDI
- FDA Product Code
- LSL FDA UDI
- GMDN Term
- Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 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: Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)
digene® HC2 CT/GC DNA Test by QIAGEN Sciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT).
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 Sciences LLC
Sources (1)
- FDA UDI f19fef6a-d909-442e-abf5-2eac83532d88 33 fields · synced May 30, 2026