Identity
- Trade Name
- digene® HC2 DNA Collection Device FDA UDI
- Generic Name
- Urogenital specimen collection kit IVD, clinical FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- 619204 FDA UDI
- Primary DI / UDI-DI
- 14053228010354 FDA UDI
- 510(k) Number
- K971586 FDA UDI
- FDA Product Code
- HHT FDA UDI
- GMDN Term
- Urogenital specimen collection kit IVD, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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: Urogenital specimen collection kit IVD, clinical
digene® HC2 DNA Collection Device by QIAGEN Sciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Urogenital specimen collection kit IVD, clinical.
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- Medscand Pap-Perfect Supply Tray — CooperSurgical, Inc. · Class II
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- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON DICKINSON AND COMPANY · Class III
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 8d58de16-f9fa-48b5-af00-32a8b3c9e6df 34 fields · synced May 30, 2026