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 ID08809317540535
NIH Device Record Key5f309a29-3466-415f-a681-6af75b5b4a25
Commercial Distribution StatusIn Commercial Distribution
Brand NameFREND
Version Model NumberFREND PSA Plus Linearity Kit
Catalog NumberFLK-PSA
Company DUNS687910463
Company NameNanoEnTek, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809317540535 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-11-04
Device Publish Date2018-10-01

On-Brand Devices [FREND]

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

Trademark Results [FREND]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREND
FREND
85028377 not registered Dead/Abandoned
Home Dialysis Plus, Ltd.
2010-05-03
FREND
FREND
79116983 4303411 Live/Registered
NANOENTEK, INC.
2012-02-02
FREND
FREND
77781495 not registered Dead/Abandoned
Dane Lee Gabriel
2009-07-15

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