FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674863342
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:48mL×2 R2:24mL×1
Published
2023-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
06971674863342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674863342069716748633426971674863342

GMDN Terms#

Term, Definition table
TermDefinition
Total lactate dehydrogenase (LDH) 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 quantitative measurement of total lactate dehydrogenase (LDH) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420046355
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
06971674866664BIOBASER1:60mL×2 R2:20mL×22023-07-22
06971674866671BIOBASER1:18mL×4 R2:6mL×42023-07-22
06971674866688BIOBASER1:18mL×1 R2:6mL×12023-07-22
06971674867920BIOBASECalibrator: 1mL×12023-07-22
06971674868255BIOBASEControl: 1mL×12023-07-22
06971674866190BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866206BIOBASER1:40mL×2 R2:20mL×22023-07-22
06971674866213BIOBASER1:20mL×4 R2:10mL×42023-07-22
06971674866220BIOBASER1:20mL×1 R2:10mL×12023-07-22
06971674866237BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866244BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866251BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674868231BIOBASEControl:1mL×12023-07-22
06971674867272BIOBASER1:60mL×2 R2:20mL×22023-07-24
06971674867289BIOBASER1:18mL×4 R2:6mL×42023-07-24
06971674867296BIOBASER1:18mL×1 R2:6mL×12023-07-24
06971674867302BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867319BIOBASER1:90mL×1 R2:30mL×12023-07-24
06971674867326BIOBASER1:48mL×2 R2:16mL×22023-07-24
06971674867777BIOBASECalibrator:1mL×12023-07-24

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
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
07613336121368Lactate Dehydrogenase acc. to IFCC ver.2Roche Diagnostics GmbHCFJ2020-03-05