Identity
- Trade Name
- TransPRO FDA UDI
- Generic Name
- Microbiological transport medium IVD FDA UDI
- Device Name
- TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. FDA UDI
- Model / Reference
- TPV50 FDA UDI
- Description
- TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-tip, flocked swab with 80mm breakpoint. Hardy Diagnostics’ Viral Transport Medium (VTM) is intended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory. FDA UDI
Identifiers
- Catalog Number
- TPV50 FDA UDI
- Primary DI / UDI-DI
- 00816576026067 FDA UDI
- 510(k) Number
- K233534 FDA UDI
- FDA Product Code
- JSM FDA UDI
- GMDN Term
- Microbiological transport medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 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
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: Microbiological transport medium IVD
TransPRO by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 05383e32-a08e-4505-b540-b900a303fa26 37 fields · synced Jun 6, 2026