ADAM-rWBC Kit AD1K-050

GUDID 08809317540269

It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.

NanoEnTek, Inc.

White blood cell count IVD, reagent

• Primary Device ID: 08809317540269
• NIH Device Record Key: f15d674d-d890-4b79-840f-c0501c3ac977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAM-rWBC Kit
• Version Model Number: AD1K-050
• Catalog Number: AD1K-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: true
• Lot Batch: true
• Serial Number: true
• 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	08809317540269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120015

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2016-09-30

Devices Manufactured by NanoEnTek, Inc.

• 08809317540252 - ADAM-rWBC: 2024-07-23 ADAM-rWBC is a device to count white blood cell. It is used with ADAM-rWBC kit.
• 08809317540269 - ADAM-rWBC Kit: 2024-07-23It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.
• 08809317540269 - ADAM-rWBC Kit: 2024-07-23 It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-
• 08809317540276 - ADAM-rWBC System: 2024-07-23 ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the quali
• 08809317540498 - ADAM-rWBC2: 2024-07-23 ADAM-rWBC2 is a device to count white blood cell. It is used with ADAM-rWBC Kit.
• 08809317540504 - ADAM-rWBC2 System: 2024-07-23 ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent). This system is intended to be used for the qua
• 08809317540016 - FREND TSH: 2024-07-22 It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System.
• 08809317540191 - FREND Free T4: 2024-07-22 It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System.
• 08809317540337 - FREND Vitamin D: 2024-07-22 It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plas