FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674860266
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R:40mL×4
Published
2023-07-11
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
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674860266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674860266069716748602666971674860266

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride 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 triglycerides 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
00850053916151IDG/SanzayIDG/SANZAY CorporationCDT2024-01-12
10673486002256Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-30
10673486002270Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-28
10673486002287Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-28
10673486002294Teco Diagnostics Triglyceride Reagent Kit TC-MatrixTECO DIAGNOSTICSCDT2023-11-28
10673486002225Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
10673486002232Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
06971674860228BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860280BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860303BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860310BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860327BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860334BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860341BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860358BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860365BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860372BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860389BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674868088BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860204BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860211BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860235BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860242BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860259BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860273BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860297BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
05055273209549TRIGLYCERIDES (TRIGS)RANDOX LABORATORIES LIMITEDCDT2022-10-05
00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213CAROLINA LIQUID CHEMISTRIES CORPORATIONCDT2022-08-19
00817302024265CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT CC213CAROLINA LIQUID CHEMISTRIES CORPORATIONCDT2022-08-19
00817302024425CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT DT213CAROLINA LIQUID CHEMISTRIES CORPORATIONCDT2022-08-19