r-Control RBC and PLT ADRC 020

GUDID 08809317541143

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.

NanoEnTek, Inc.

White blood cell count IVD, control

• Primary Device ID: 08809317541143
• NIH Device Record Key: f68d0407-ee84-49d1-b2b7-3af64a10cb82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: r-Control RBC and PLT
• Version Model Number: ADRC 020
• Catalog Number: ADRC 020
• Company DUNS: 687910463
• Company Name: NanoEnTek, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809317541143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK210621

FDA Product Code

• MZG: Test, Residual, Wbc In Leukoreduced Blood

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-16
• Device Publish Date: 2021-12-08

Devices Manufactured by NanoEnTek, Inc.

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