Identity
- Trade Name
- digene® HC2 GC-ID 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
- 5140-1220 FDA UDI
- Primary DI / UDI-DI
- 04053228010296 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)
digene® HC2 GC-ID DNA Test by QIAGEN Sciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT).
- BD ProbeTec™ Neisseria gonorrhoeae (GC) Qx Assay Gray Amp Reagent Pack — BECTON DICKINSON AND COMPANY · Class II
- Aptima® — Hologic, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- digene® HC2 CT/GC DNA Test — QIAGEN Sciences LLC · Class II
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 99470833-91a7-43f8-ba4b-d35d969afdf3 33 fields · synced May 30, 2026