FDA.reportPublic FDA data

Cyclosporine C2 Control

Primary DI
00856743007055
Brand
Cyclosporine C2 Control
Company
MORE DIAGNOSTICS INC
Model
202
Catalog number
202
Device description
MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood.
Published
2018-04-03
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
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932662000CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVELMore Diagnostics1993-07-26LAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856743007055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856743007055008567430070558567430070550856743007055

GMDN Terms#

Term, Definition table
TermDefinition
Cyclosporin A/cyclosporine 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 the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.

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
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
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
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

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Primary DI, Brand, Company table
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