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PCRopsis

FDA UDI

Class I (US FDA UDI)

by Entopsis, Llc

Identity

Trade Name
PCRopsis FDA UDI
Generic Name
Viral transport medium IVD FDA UDI
Device Name
PCRopsis™ Universal Viral Transport (UVT) 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. PCRopsis™ UVT (1.5 mL) is aliquoted into 100x sterile, 10 mL transport tubes. FDA UDI
Model / Reference
Universal Viral Transport (100x 1.5 mL) FDA UDI
Description
PCRopsis™ Universal Viral Transport (UVT) 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. PCRopsis™ UVT (1.5 mL) is aliquoted into 100x sterile, 10 mL transport tubes. FDA UDI

Identifiers

Catalog Number
88810015 FDA UDI
Primary DI / UDI-DI
B550888100158 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

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Manufacturer

Manufacturer
Entopsis, Llc

Sources (1)

  • FDA UDI 3450af6e-9486-408c-89d2-916f79a431f8 35 fields · synced May 30, 2026