PCRopsis

Basic Information

• Brand Name: PCRopsis
• Primary DI: B550888100158
• Version / Model: Universal Viral Transport (100x 1.5 mL)
• Catalog Number: 88810015
• Company Name: ENTOPSIS, LLC
• Labeler DUNS: 078294784
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-10-29
• Public Version: 2
• Public Version Date: 2021-03-18
• Public Version Status: Update
• Public Device Record Key: 3450af6e-9486-408c-89d2-916f79a431f8
• Distribution End Date: 2020-12-01

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JSM	Culture Media, Non-Propagating Transport	Microbiology	866.2390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58697	Viral transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of viral culture isolates from a clinical specimen.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B550888100158	HIBCC
Unit of Use	B55088800015	HIBCC