FREND FLK-PSA

GUDID 08809317540535

FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only. FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.

NanoEnTek, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent

• Primary Device ID: 08809317540535
• NIH Device Record Key: 5f309a29-3466-415f-a681-6af75b5b4a25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREND
• Version Model Number: FREND PSA Plus Linearity Kit
• Catalog Number: FLK-PSA
• 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: true
• Device Combination Product: false
• Single Use: true
• 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	08809317540535 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2020-11-04
• Device Publish Date: 2018-10-01

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.