FREND System F20

GUDID 08809317541259

FREND System is designed for reding the FREND cartridge of a quantitative.

NanoEnTek, Inc.

Fluorescent immunoassay analyser IVD, point-of-care

• Primary Device ID: 08809317541259
• NIH Device Record Key: a83af94a-62d2-448a-910f-05bf5b2675d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREND System
• Version Model Number: FREND 2.0
• Catalog Number: F20
• 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	08809317541259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124056

FDA Product Code

• KHO: Fluorometer, For Clinical Use

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: 2024-07-08
• Device Publish Date: 2024-06-30

Devices Manufactured by NanoEnTek, Inc.

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• 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