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BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Kit HSV 1/Hsv2 Qx Amplified Dna Assay FDA UDI
- Model / Reference
- 441749 FDA UDI
- Description
- Kit HSV 1/Hsv2 Qx Amplified Dna Assay FDA UDI
Identifiers
- Catalog Number
- 441749 FDA UDI
- Primary DI / UDI-DI
- 00382904417499 FDA UDI
- 510(k) Number
- K103798 FDA UDI
- FDA Product Code
- OQO FDA UDI
- GMDN Term
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3305 FDA UDI
- Commercial Distribution
- Not 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
BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID
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
- Becton Dickinson And Company
Sources (1)
- FDA UDI 5164c1b6-fc36-4735-99fe-873f6409e44d 38 fields · synced May 30, 2026