FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274021330
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
CPK2-120
Device description
CPK LIQUID (1x 120mL R1, 1x 30mL R2)
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
CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGSNad Reduction/Nadh Oxidation, Cpk Or IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013912000CREATINE KINASE (CK-NAC)Jas Diagnostics, Inc.2002-01-18CGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274021330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021330008172740213308172740213300817274021330

GMDN Terms#

Term, Definition table
TermDefinition
Total creatine kinase (CK) IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of total creatine kinase (CK) in a clinical specimen.

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
00850053916090IDG/SanzayIDG/SANZAY CorporationCGS2024-01-09
10673486001648Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent SetTECO DIAGNOSTICSCGS2023-11-17
10673486001655Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent SetTECO DIAGNOSTICSCGS2023-11-17
10673486001495Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSCGS2023-07-27
10673486001501Teco Diagnostics Creatine Kinase (CK-NAC) Reagent SetTECO DIAGNOSTICSCGS2023-07-27
10673486001594Teco Diagnostics Creatine Kinase (CK-NAC) Liquid ReagentTECO DIAGNOSTICSCGS2023-07-27
10673486001617Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC MatrixTECO DIAGNOSTICSCGS2023-07-27
00811727016096Pointe Creatine Kinase ReagentHORIBA INSTRUMENTS INCORPORATEDCGS2021-01-30
03610230006948Yumizen C1200 CK-NACHORIBA ABX SASCGS2020-08-31
00811727015785Pointe Creatine Kinase for BS480HORIBA INSTRUMENTS INCORPORATEDCGS2020-05-28
00380740161699ARCHITECTAbbott GmbHCGS2020-01-25
00380740161705ARCHITECTAbbott GmbHCGS2020-01-25
00380740132590AlinityAbbott GmbHCGS2019-05-07
00386100002183CK Reagent Kit MEDICA CORPORATIONCGS2019-02-14
00630414008943ADVIA Chemistry Creatine KinaseSiemens Healthcare Diagnostics Inc.CGS2018-11-12
00628063401079Creatine Kinase AssaySEKISUI DIAGNOSTICS, LLCCGS2018-09-24
00852169008089ClearChem Diagnostics Inc. Creatine Kinase (CK)CLEARCHEM DIAGNOSTICS INC.CGS2018-04-30
00630414006642Atellica CH CK_LSiemens Healthcare Diagnostics Inc.CGS2017-12-21
05060500091866Synermed®INFRARED LABORATORY SYSTEMS LLCCGS2017-02-28
00817302023039CAROLINA LIQUID CHEMISTRIES CORP.® CK REAGENT PRODUCT NO. DT207CAROLINA LIQUID CHEMISTRIES CORPORATIONCGS2016-10-17
00817302022940CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692CAROLINA LIQUID CHEMISTRIES CORPORATIONCGS2016-10-12
00812137011954CK-NAC Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CGS2016-10-12
15099590010744AUBeckman Coulter, Inc.CGS2016-09-24
15099590020262AUBeckman Coulter, Inc.CGS2016-09-24
00842768025556Dimension® Flex® reagent cartridge MBISiemens Healthcare Diagnostics Inc.CGS2016-09-24
00842768027925Dimension Vista® Flex® reagent cartridge CKISiemens Healthcare Diagnostics Inc.CGS2016-09-24
00857969006075ACEALFA WASSERMANN, INC.CGS2016-09-24
00857969006143ACEALFA WASSERMANN, INC.CGS2016-09-24
00630414209746ADVIA® Chemistry CKNAC Creatine Kinase ReagentsSiemens Healthcare Diagnostics Inc.CGS2016-09-24
00630414508337ADVIA® Chemistry CKNAC Creatine Kinase ReagentsSiemens Healthcare Diagnostics Inc.CGS2016-09-24