FDA.reportPublic FDA data

CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692

Primary DI
00817302022940
Brand
CAROLINA LIQUID CHEMISTRIES CORP.® CKMB CC692
Company
CAROLINA LIQUID CHEMISTRIES CORPORATION
Model
CC692
Catalog number
CC692
Device description
CKMB 2 x 60 tests
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817302022940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817302022940008173020229408173020229400817302022940

GMDN Terms#

Term, Definition table
TermDefinition
Creatine kinase myocardial isoenzyme (CKMB) 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 creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Reagent is stable when stored at 2-8° C until expiration date

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)471-7272ContactSales@CarolinaChemistries.com

Regulatory Flags#

DUNS number
962385787
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817302022353Carolina Liquid Chemistries Corp. Basic Multi-Drug Control SetCC4492023-03-27
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCLCE11062023-03-10
00817302022346Carolina Liquid Chemistries Corp. Fentanyl Detection KitCLCF650252023-03-10
00817302024678CAROLINA LIQUID CHEMISTRIES CORP.® OXIDANT REAGENT CC445CC445CC4452022-12-03
00817302024654Caldon Biotech Aldolase ReagentCALD-015CALD-0152022-11-30
00817302024661Caldon Biotech Serum Aldolase ControlsCOAL-015COAL-0152022-11-30
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240AU-240AU-2402022-10-18
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220AU-220AU-2202022-08-19
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218AU-240AU-2402022-08-19
00817302024128CAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT AU-618AU-618AU-6182022-08-19
00817302024135CAROLINA LIQUID CHEMISTRIES CORP.® LIPASE REAGENT KIT AU-621AU-621AU-6212022-08-19
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661AU-661AU-6612022-08-19
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209BL209BL2092022-08-19
00817302024166CAROLINA LIQUID CHEMISTRIES CORP.® CHOLESTEROL REAGENT KIT BL211BL211BL2112022-08-19
00817302024173CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT BL212BL212BL2122022-08-19
00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213BL213BL2132022-08-19
00817302024197CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218BL218BL2182022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220BL220BL2202022-08-19
00817302024210CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240BL240BL2402022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661BL661BL6612022-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 ReagentPOINTE SCIENTIFIC, INC.CGS2021-01-30
03610230006948Yumizen C1200 CK-NACHORIBA ABX SASCGS2020-08-31
00811727015785Pointe Creatine Kinase for BS480HORIBA INSTRUMENTS INCORPORATEDCGS2020-05-28
00380740161699ARCHITECTAbbott GmbH & Co. KGCGS2020-01-25
00380740161705ARCHITECTAbbott GmbH & Co. KGCGS2020-01-25
00380740132590AlinityAbbott GmbH & Co. KGCGS2019-05-07
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
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
00015482771027SPOTCHEM™ II Uric AcidARKRAY USA, INC.CGS2016-09-23
00015482771126SPOTCHEM™ II CPKARKRAY USA, INC.CGS2016-09-23