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Control Set for the BD ProbeTec™ Herpes Simplex Viruses
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Control Set for the BD ProbeTec™ Herpes Simplex Viruses FDA UDI
- Generic Name
- Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control FDA UDI
- Device Name
- Set HSV 1 And 2 Control FDA UDI
- Model / Reference
- 441748 FDA UDI
- Description
- Set HSV 1 And 2 Control FDA UDI
Identifiers
- Catalog Number
- 441748 FDA UDI
- Primary DI / UDI-DI
- 00382904417482 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, control 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
Control Set for the BD ProbeTec™ Herpes Simplex Viruses 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 de8bb787-93d0-4b0b-bf99-1f7a4b838330 38 fields · synced May 29, 2026