FDA.reportPublic FDA data

Whole Blood Matrix

Primary DI
00856743007000
Brand
Whole Blood Matrix
Company
MORE DIAGNOSTICS INC
Model
375-B
Catalog number
375-B
Device description
MORE DIAGNOSTICS Whole Blood Matrix is intended to be used as a whole blood matrix and zero level control product to check calibration in chemistry analyzers which measure everolimus, rapamycin (sirolimus), tacrolimus, and cyclosporine.
Published
2020-06-17
Public version status
New
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856743007000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856743007000008567430070008567430070000856743007000

GMDN Terms#

Term, Definition table
TermDefinition
Multiple immunosuppressant therapeutic drug monitoring IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple immunosuppressant drugs which may include cyclosporin A (or cyclosporine), tacrolimus, sirolimus and/or everolimus, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-14 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-758-0978info@morediagnostics.com

Regulatory Flags#

DUNS number
829978451
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856743007116Whole Blood Matrix275-B275-B2020-06-17
00856743007277EV/TAC/CsA Control3053052019-08-06
00856743007284EV/TAC/CsA Control305-1305-12019-08-06
00856743007291EV/TAC/CsA Control305-2305-22019-08-06
00856743007307EV/TAC/CsA Control305-3305-32019-08-06
00856743007017Cardiac Marker Control1501502018-03-30
00856743007024Cardiac Control Marker150-1150-12018-03-31
00856743007031Cardiac Marker Control150-2150-22018-03-31
00856743007048Cardiac Marker Control150-3150-32018-03-31
00856743007055Cyclosporine C2 Control2022022018-04-03
00856743007062MPA Control2402402018-04-05
00856743007079MPA Control240-1240-12018-04-04
00856743007086MPA Control240-2240-22018-04-05
00856743007093MPA Control240-3240-32018-04-05
00856743007109MPA Control240-4240-42018-04-05
00856743007123Rap/Tac/CsA Control280-1280-12018-04-05
00856743007130Rap/Tac/CsA Control280-2280-22018-04-05
00856743007147Rap/Tac/CsA Control280-3280-32018-04-05
00856743007154Rap/Tac/CsA Control2852852018-04-05
00856743007161Rap/Tac/CsA Control285-1285-12018-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
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00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
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00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
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00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08