ADAM ADAM2

GUDID 08809317540627

ADAMII is a device to count stained CD series (e.g. CD34, CD3, CD4, CD8, CD45, etc.) in human sample as an aid in the management of patients.

NanoEnTek, Inc.

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• Primary Device ID: 08809317540627
• NIH Device Record Key: 0a0a438f-54dc-48b5-8a8f-6d32fccd7665
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAM
• Version Model Number: ADAMII
• Catalog Number: ADAM2
• 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: true
• 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	08809317540627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180283

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: 2020-09-10
• Device Publish Date: 2020-09-02

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