ADAM

GUDID 08809317540993

The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cells (rWBCs) in leukoreduced blood products.

NanoEnTek, Inc.

White blood cell count IVD, kit, cell count

• Primary Device ID: 08809317540993
• NIH Device Record Key: f06b1a17-e09d-41f3-b4dc-80bfa1fce13f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAM
• Version Model Number: ADAM-rWBC HT
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	08809317540993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK200525

FDA Product Code

• GKZ: Counter, Differential Cell

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: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [ADAM]

• 08809317540634: ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluorescenc
• 08809317540627: ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sa
• 08809317541006: It is used for the quantitative determination of the residual white blood cell (leukocyte) count
• 08809317540993: The ADAM-rWBC HT residual leukocyte counter is a designed for counting residual white blood cell