4Kscore Test

Primary DI
00850038860004
Brand
4Kscore Test
Company
Bioreference Health, LLC
Model
1
Device description
4Kscore Specimen Collection Kit
Published
2022-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate CancerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P1900220004Kscore TestOpko Health, Inc.2021-12-07QRF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038860004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038860004008500388600048500388600040850038860004

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection set, noninvasiveA collection of sterile, noninvasive devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes and a separate blood access device (e.g., intravenous catheter), for the routine collection of multiple blood specimens from a patient, for clinical analyses. It consists of various device combinations that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder; the set may connect to, but does not contain, an invasive blood access device(s) [e.g., an intravenous catheter]. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.229.5227bamaral@bioreference.com
800-229-5227ksiedel@bioreference.com

Regulatory Flags#

DUNS number
121571798
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860012266708IsoPSA ReagentCleveland Diagnostics, Inc.QRF2026-04-14
00860012266715IsoPSA ControlsCleveland Diagnostics, Inc.QRF2026-04-14