Identity
- Trade Name
- BD Viper™ LT System PCR Tube/Tray Kit FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- BD Viper™ LT System PCR Tube/Tray Kit FDA UDI
- Model / Reference
- 442957 FDA UDI
- Description
- BD Viper™ LT System PCR Tube/Tray Kit FDA UDI
Identifiers
- Catalog Number
- 442957 FDA UDI
- Primary DI / UDI-DI
- 00382904429577 FDA UDI
- PMA Number
- P160037 FDA UDI
- FDA Product Code
- MAQ FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System PCR Tube/Tray Kit by Becton Dickinson And Company — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI f6638a25-5bee-4219-a738-3308120d279b 37 fields · synced Jun 1, 2026