Identity
- Trade Name
- digene® Wash Buffer Concentrate FDA UDI
- Generic Name
- Human papillomavirus (HPV) antigen IVD, reagent FDA UDI
- Device Name
- digene® Wash Buffer Concentrate (paired with 5199-00016 High-risk 4-plate) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- digene® Wash Buffer Concentrate (paired with 5199-00016 High-risk 4-plate) FDA UDI
Identifiers
- Catalog Number
- 5100-00047 FDA UDI
- Primary DI / UDI-DI
- 14053228002014 FDA UDI
- PMA Number
- P890064 FDA UDI
- FDA Product Code
- MAQ FDA UDI
- GMDN Term
- Human papillomavirus (HPV) antigen IVD, reagent 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
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: Human papillomavirus (HPV) antigen IVD, reagent
digene® Wash Buffer Concentrate by QIAGEN Sciences LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 716f2a51-0d44-4a16-9cdb-0b53b7561f8c 35 fields · synced May 30, 2026