Identity
- Trade Name
- BD Onclarity™ HPV Assay Reagent Pack FDA UDI
- Generic Name
- Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Kit HPV Assay Reagent for BD COR US FDA UDI
- Model / Reference
- 444075 FDA UDI
- Description
- Kit HPV Assay Reagent for BD COR US FDA UDI
Identifiers
- Catalog Number
- 444075 FDA UDI
- Primary DI / UDI-DI
- 00382904440756 FDA UDI
- PMA Number
- P160037 FDA UDI
- FDA Product Code
- MAQ FDA UDI
- GMDN Term
- Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class III 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
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) nucleic acid IVD, kit, nucleic acid technique (NAT)
BD Onclarity™ HPV Assay Reagent Pack by Becton Dickinson And Company — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT).
- BD FOX™ PCR Extraction Tubes — BECTON DICKINSON AND COMPANY · Class III
- BD Control Set for the BD Onclarity™ HPV Assay — BECTON DICKINSON AND COMPANY · Class III
- BD Viper™ PCR Extraction Reagent Trough with Piecring Tool — BECTON DICKINSON AND COMPANY · Class III
- BD Onclarity™ HPV Extraction Reagent Trough for BD COR™ — BECTON DICKINSON AND COMPANY · Class III
- BD Onclarity™ HPV Assay Reagent Pack — BECTON DICKINSON AND COMPANY · Class III
Cleared under the same submission
P160037 also covers:
- BD COR™ GX INSTRUMENT — BECTON DICKINSON AND COMPANY
- BD COR™ PX INSTRUMENT — BECTON DICKINSON AND COMPANY
- BD Control Set for the BD Onclarity™ HPV Assay — BECTON DICKINSON AND COMPANY
- BD Copan FLOQSwabs for HPV Self Collection — BECTON DICKINSON AND COMPANY
- BD FOX™ PCR Extraction Tubes — BECTON DICKINSON AND COMPANY
- BD Onclarity HPV Self Collection Diluent Tube — BECTON DICKINSON AND COMPANY
- BD Onclarity™ HPV Assay Diluent for BD COR™ — BECTON DICKINSON AND COMPANY
- BD Onclarity™ HPV Assay Reagent Pack — BECTON DICKINSON AND COMPANY
- BD Onclarity™ HPV Extraction Reagent Trough for BD COR™ — BECTON DICKINSON AND COMPANY
- BD Onclarity™ HPV LBC Diluent Tubes — BECTON DICKINSON AND COMPANY
- BD Onclarity™ HPV SurePath™ Diluent Tubes — BECTON DICKINSON AND COMPANY
- BD Viper™ LT System PCR Accessory kit — BECTON DICKINSON AND COMPANY
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
- Becton Dickinson And Company
Sources (1)
- FDA UDI 6bc1e4b5-19fe-4b00-a5c3-49707fcedb06 37 fields · synced May 30, 2026