FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274021293
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
CKMB-BUP
Device description
CK MB ISOENZYME POWDER
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JHWU.V. Method, Cpk Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHWU.V. Method, Cpk IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K942958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K942958000CREATINE KINASE MB DETERMINATION (UV)Biochemical Trade, Inc.1994-11-21JHW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274021293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021293008172740212938172740212930817274021293

GMDN Terms#

Term, Definition table
TermDefinition
Total creatine kinase (CK) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-305-324-2300customersupport@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817274020425Drew ScientificR12A24D-BUL2016-09-09
00817274021743JAS DiagnosticsA1CC1-0.52016-09-09
00817274021804JAS DiagnosticsLDH2-30R2U2016-09-12
00817274021811JAS DiagnosticsXL-LDH2-402016-09-12
00817274021828JAS DiagnosticsLDH2-120R1U2016-09-12
00817274021835JAS DiagnosticsLDH2-R1-BUL2016-09-12
00817274021842JAS DiagnosticsLDH2-R2-BUL2016-09-12
00817274021859JAS DiagnosticsDG-LDH2-1202016-09-12
00817274021866JAS DiagnosticsLDH2-1202016-09-12
00817274021873JAS DiagnosticsLDH2-1L2016-09-12
00817274020517Drew ScientificDSJ-9001-0012016-09-09
00817274020524DrewDSJ-9001-0212016-09-09
00817274021491JAS DiagnosticsBAS-9001-1812016-09-09
00817274022214JAS DiagnosticsTA1039802016-09-12
00817274022221JAS DiagnosticsTA1035772016-09-12
00817274020692JAS DiagnosticsALP2-1L2016-09-09
00817274020708JAS DiagnosticsXL-ALP2-402016-09-09
00817274020715JAS DiagnosticsALP2-120R1U2016-09-09
00817274020722JAS DiagnosticsALP2-30R2U2016-09-09
00817274020739JAS DiagnosticsALT2-P1L2016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811727018632Pointe Scientific CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2021-02-28
00811727018649Pointe Scientific CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2021-02-28
00657498001547CK-MB Liqui-UV®STANBIO LABORATORY, L.P.JHW2016-10-11
00657498000748CK-MB TestSTANBIO LABORATORY, L.P.JHW2016-09-23
00817274021309JAS DiagnosticsDREW SCIENTIFIC, INC.JHW2016-09-09
00817274021316JAS DiagnosticsDREW SCIENTIFIC, INC.JHW2016-09-09
00811727010940POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31
00811727010957POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31
00811727010964POINTE SCIENTIFIC CK-MBHORIBA INSTRUMENTS INCORPORATEDJHW2016-08-31