FDA.reportPublic FDA data

EV/TAC/CsA Control

Primary DI
00856743007307
Brand
EV/TAC/CsA Control
Company
MORE DIAGNOSTICS INC
Model
305-3
Catalog number
305-3
Device description
MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of everolimus, tacrolimus, and cyclosporine.
Published
2019-08-06
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
00856743007307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856743007307008567430073078567430073070856743007307

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
00856743007000Whole Blood Matrix375-B375-B2020-06-17
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
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
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05700699445209S7630 QUALICHECK 7+, level 1 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445216S7640 QUALICHECK 7+, level 2 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445223S7650 QUALICHECK 7+, level 3 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
05700699445230S7660 QUALICHECK 7+, level 4 box of 10 ampoules for ABL90 FLEX, ABL90Radiometer Medical ApSJJY2026-10-30
00850010224497CareSuperb COVID-19 Antigen External ControlAccess Bio Inc.JJY2026-10-01
10673486014112Teco Diagnostics TC-TROL (N) Serum Control Level I HumanTECO DIAGNOSTICSJJY2026-08-25
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00850011135556VALIDATELgc Clinical Diagnostics, Inc.JJY2026-07-07
00850011135853ValidateLgc Clinical Diagnostics, Inc.JJY2026-07-07
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05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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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
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