PCRopsis

Basic Information

• Brand Name: PCRopsis
• Primary DI: B550227610000
• Version / Model: BCS Nano
• Catalog Number: 22761000
• Company Name: ENTOPSIS, LLC
• Labeler DUNS: 078294784
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-08
• Public Version: 2
• Public Version Date: 2024-04-12
• Public Version Status: Update
• Public Device Record Key: 01f4c779-e29f-4e93-bcc7-a50ebd9c3e65
• Distribution End Date: 2023-01-01

Device Description

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.

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
62886	Red blood cell separation reagent	A substance or reactant intended to be used for the isolation of red blood cells (RBCs) from a whole blood clinical specimen by promoting aggregation of RBCs. It is primarily used in a blood bank or transfusion centre for blood component separation (e.g., isolation of stem cells from cord blood); it may also be used to facilitate in vitro examination of specimens by way of reducing the availability of cells not relevant to the diagnostic process.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B550227610000	HIBCC