FDA.reportPublic FDA data

GENCHEM™ CK-NAC Reagent

Primary DI
00851445007136
Brand
GENCHEM™ CK-NAC Reagent
Company
GENCHEM INC
Model
GEN-CK R1
Catalog number
GEN-CK R1
Device description
10/17/2022
Published
2016-09-19
Public version status
Update
Distribution status
Not 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
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
K974833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974833000CK-NAC REAGENTIntersect Systems, Inc.1998-02-13CGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851445007136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851445007136008514450071368514450071360851445007136

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase (CK) multiple isoenzyme IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple creatine kinase (CK) isoenzymes in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(714)529-7125lorlow@genchem.org

Regulatory Flags#

DUNS number
193856866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851445007006GENCHEM™ Albumin ReagentGEN-ALBGEN-ALB2016-09-19
00851445007013GENCHEM™ Albumin ReagentGEN-ALB-GGEN-ALB-G2016-09-19
00851445007020GENCHEM™ Alkaline PhosphataseGEN-ALP R1GEN-ALP R12016-09-19
00851445007037GENCHEM™ Alkaline PhosphataseGEN-ALP R2GEN-ALP R22016-09-19
00851445007044GENCHEM™ Amylase ReagentGEN-AMYGEN-AMY2016-09-19
00851445007099GENCHEM™Calcium, Azo Dye ReagentGEN-CA3GEN-CA32016-09-19
00851445007211GENCHEM™ Glucose Oxidase ReagentGEN-GLU3GEN-GLU32016-09-19
00851445007228GENCHEM™ Glucose Oxidase ReagentGEN-GLU LXGEN-GLU LX2016-09-19
00851445007235GENCHEM™ Glucose ReagentGEN-GLU4GEN-GLU42016-09-19
00851445007051GENCHEM™ AST/SGOTGEN-AST R1GEN-AST R12016-09-19
00851445007068GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN LXGEN-BUN LX2016-09-19
00851445007075GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagentGEN-BUN3GEN-BUN32016-09-19
00851445007082GENCHEM™ UREAGEN-BUN R1GEN-BUN R12016-09-19
00851445007105GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1GEN-CAL 1GEN-CAL 12016-09-19
00851445007112GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2GEN-CAL 2GEN-CAL 22016-09-19
00851445007129GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3GEN-CAL 3GEN-CAL 32016-09-19
00851445007143GENCHEM™ CK-NAC ReagentGEN-CK R2GEN-CK R22016-09-19
00851445007150GENCHEM™ CO2 Acid ReagentGEN-CO2ACIDGEN-CO2ACID2016-09-19
00851445007167GENCHEM™ CO2 Acid ReagentGEN-CO2ALKGEN-CO2ALK2016-09-19
00851445007174GENCHEM™ Creatinine Test ReagentGEN-CREA R1(Base)GEN-CREA R1(Base)2016-09-19

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