AccessGUDID - DEVICE: r-Control RBC and PLT (08809317541143)

GUDID

Device Identifier (DI) Information

Brand Name: r-Control RBC and PLT
Version or Model: ADRC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADRC 020
Company Name: NanoEnTek, Inc.

Primary DI Number: 08809317541143
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687910463 *Terms of Use

Device Description: The r-Control RBC and PLT consists of red blood cell (RBC) Low & RBC High process controls and platelet (PLT) Low & PLT High process controls. It is intended for use with ADAM-rWBC Kit to monitor the process for enumeration of residual leukocytes in leukocyte reduced RBC and PLT products, including dilution, staining, instrument setup, and white blood cell (WBC) enumeration. For in vitro diagnostic use only.

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
56225	White blood cell count IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZG	Test, Residual, Wbc In Leukoreduced Blood

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK210621	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: f68d0407-ee84-49d1-b2b7-3af64a10cb82
Public Version Date: July 23, 2024
Public Version Number: 2
DI Record Publish Date: December 08, 2021