PCRopsis

Basic Information

• Brand Name: PCRopsis
• Primary DI: B55026682504
• Version / Model: Concentrator
• Catalog Number: 2668250
• Company Name: ENTOPSIS, LLC
• Labeler DUNS: 078294784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2021-05-13
• Public Version: 1
• Public Version Date: 2021-05-21
• Public Version Status: New
• Public Device Record Key: eece9e42-2804-4e40-acd2-4409d5478369

Device Description

PCRopsis™ Concentrator (250 pre-loaded tubes) concentrates clinical samples.

Device Characteristics

• Single Use: No
• 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
JJH	Clinical Sample Concentrator	Clinical Chemistry	862.2310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58385	Evaporation/filtration sample concentrator	A mains electricity (AC-powered) laboratory device designed to concentrate fluid containing solutes (dissolved substances, including salts and proteins/hormones) or other chemical compounds (drugs or toxins) by removing the water element. It typically uses heat (to encourage evaporation), membranes, or other small-pore filters that only enable the transmission of water (either by osmotic transfer or sheer physical size of the compounds, with or without the assistance of added pressure via a pump or vacuum) to reduce the fluid component. Some types may employ low pressure gas distributed via a manifold that is blown onto the fluid surface of the solution (to encourage solvent evaporation).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B550266825047	HIBCC
Primary	B55026682504	HIBCC