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.

Haematological cell analyser IVD, automated

• 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