FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674860365
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R:20mL×8
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
06971674860365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674860365069716748603656971674860365

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
06936895301882BIOBASER1:64mL×2 R2:16mL×22023-07-26
06936895301899BIOBASER1:20mL×1 R2:5mL×12023-07-26
06936895301905BIOBASER1:20mL×4 R2:5mL×42023-07-26
06936895301912BIOBASER1:60mL×5 R2:15mL×52023-07-26
06936895301929BIOBASER1:64mL×2 R2:16mL×22023-07-26
06936895301936BIOBASER1:20mL×1 R2:5mL×12023-07-26
06936895301943BIOBASER1:20mL×4 R2:5mL×42023-07-26
06936895301950BIOBASER1:60mL×5 R2:15mL×52023-07-26
06971674862932BIOBASER1:70mL×2 R2:14mL×22023-07-24
06971674862949BIOBASER1:60mL×2 R2:12mL×22023-07-24
06971674862956BIOBASER1:25mL×4 R2:5mL×42023-07-24
06971674862963BIOBASER1:25mL×1 R2:5mL×12023-07-24
06971674862970BIOBASER1:40mL×4 R2:16mL×22023-07-24
06971674862987BIOBASER1:50mL×2 R2:10mL×22023-07-24
06971674862994BIOBASER1:80mL×2 R2:16mL×22023-07-24
06971674863007BIOBASER1:100mL×1 R2:20mL×12023-07-24
06971674863014BIOBASER1:50mL×2 R2:20mL×12023-07-24
06971674863021BIOBASER1:50mL×2 R2:20mL×12023-07-24
06971674863038BIOBASER1:50mL×2 R2:10mL×22023-07-24
06971674863045BIOBASER1:50mL×2 R2:10mL×22023-07-24

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
06971674860266BIOBASEBiobase 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
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