Identity
- Trade Name
- PCRopsis FDA UDI
- Generic Name
- Viral transport medium IVD FDA UDI
- Device Name
- PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. FDA UDI
- Model / Reference
- Universal Viral Transport FDA UDI
- Description
- PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. FDA UDI
Identifiers
- Catalog Number
- 888001 FDA UDI
- Primary DI / UDI-DI
- B5508880010 FDA UDI
- FDA Product Code
- JSM FDA UDI
- GMDN Term
- Viral transport medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2390 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PCRopsis by Entopsis, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Entopsis, Llc
Sources (1)
- FDA UDI 5e8bf86d-132b-4965-a99b-cbc96ae59eab 35 fields · synced May 31, 2026