FREND F10AP

GUDID 08809317540467

NanoEnTek, Inc.

Heating block IVD

• Primary Device ID: 08809317540467
• NIH Device Record Key: 9d239ab8-6536-42e2-9bca-8df62b42b044
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREND
• Version Model Number: FREND AP
• Catalog Number: F10AP
• Company DUNS: 687910463
• Company Name: NanoEnTek, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	08809317540467 [Primary]

FDA Product Code

• JRG: Block, Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2018-06-11

On-Brand Devices [FREND]

• 08809317540481: It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specim
• 08809317540184: It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specim
• 08809317540825: FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containi
• 08809317540924: The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coron
• 08809317540917: The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab
• 08809317540566: FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid
• 08809317540559: FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid
• 08809317540542: FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the
• 08809317540535: FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the pro
• 08809317540528: FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free
• 08809317540467: FREND AP
• 08809317540375: It is used for the quantitative measurement of Total Testosterone in human serum or heparinized,
• 08809317540153: It is used for the quantitiative determination of Testosterone in human specimen using FREND Sys
• 08809317540207: FREND System is designed for reding the FREND cartridge of a quantitative.