AccessGUDID - DEVICE: PCRopsis (B55022761000)

GUDID

Device Identifier (DI) Information

Brand Name: PCRopsis
Version or Model: BCS Nano
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2276100
Company Name: ENTOPSIS, LLC

Primary DI Number: B55022761000
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 078294784 *Terms of Use

Device Description: PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f224161e-2264-44db-a325-b738932d93b2
Public Version Date: April 12, 2024
Public Version Number: 2
DI Record Publish Date: June 08, 2021