4Kscore Test

GUDID 00850038860004

4Kscore Specimen Collection Kit

Bio-Reference Laboratories, Inc.

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Primary Device ID00850038860004
NIH Device Record Key4ab5f4eb-e9ab-4aa6-9429-04285e472680
Commercial Distribution StatusIn Commercial Distribution
Brand Name4Kscore Test
Version Model Number1
Company DUNS121571798
Company NameBio-Reference Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Customer Support Contacts

Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com
Phone800.229.5227
Emailbamaral@bioreference.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850038860004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-10
Device Publish Date2022-02-02

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