ADAM CD34K-050

GUDID 08809317540634

ADAMII-CD34 Kit is designed for use with the ADAMII instrument, benchtop image-based fluorescence cell counter. ADAMII-CD34 Kit provides the percentages of total and viable cells that are CD34+(%CD34).

NanoEnTek, Inc.

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• Primary Device ID: 08809317540634
• NIH Device Record Key: 69d13cc8-c8c2-4af5-a341-7bd6032f5752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAM
• Version Model Number: CD34K-050
• Catalog Number: CD34K-050
• 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	08809317540634 [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