FDA.reportPublic FDA data

Lactate Dehydrogenase Kit (Kinetic Method)

Primary DI
06970291985178
Brand
Lactate Dehydrogenase Kit (Kinetic Method)
Company
Medicalsystem Biotechnology Co., Ltd.
Model
None
Published
2019-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFJNad Reduction/Nadh Oxidation, Lactate DehydrogenaseClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970291985178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970291985178069702919851786970291985178

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545261989
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970291985222Microalbuminuria Kit (Immunoturbidimetric Method)None2019-03-07
06970291985185Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Method)None2019-03-07
06970291985154Aspartate Aminotransferase Kit (Colorimetric Method )None2019-03-07
06970291985215β2-Microglobin Kit (Latex-Enhanced Immunoturbidimetric Method)None2019-03-07
06970291985161Haptoglobin Kit (Immunoturbidimetric Method)None2019-03-07
06970291985192Total Protein Kit (Biuret Method)None2019-03-07
06970291985208Total Protein Kit (Biuret Method) (2-Part Reagents)None2019-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740155322AlinityABBOTT IRELANDCFJ2025-12-19
00380740155339AlinityABBOTT IRELANDCFJ2025-12-19
00380740195236ARCHITECTABBOTT IRELANDCFJ2025-12-19
00380740195243ARCHITECTABBOTT IRELANDCFJ2025-12-19
00850053916137IDG/SanzayIDG/SANZAY CorporationCFJ2024-01-12
10673486002027Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002034Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
10673486002041Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002058Teco Diagnostics LDH Liquid Reagent Kit for TC MatrixTECO DIAGNOSTICSCFJ2023-11-13
10673486002065Teco Diagnostics LDH-L Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
10673486002072Teco Diagnostics LDH-L Reagent SetTECO DIAGNOSTICSCFJ2023-11-13
06971674863267BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863274BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863281BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863298BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863304BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863311BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863328BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863335BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863342BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863359BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863366BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863373BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
06971674863380BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CFJ2023-07-21
00811727015891Pointe Lactate Reagent HORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727015907Pointe Lactate Dehydrogenase ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727016195Pointe Lactic Acid ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
00811727016201Pointe Lactate Dehydrogenase ReagentHORIBA INSTRUMENTS INCORPORATEDCFJ2021-01-30
03610230007075Yumizen C1200 LDHHORIBA ABX SASCFJ2020-08-28
10758750031108VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CFJ2020-04-18