FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674860679
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:48mL×2 R2:16mL×2
Published
2023-07-12
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
MRRSystem, Test, Low Density, Lipoprotein

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRRSystem, Test, Low Density, LipoproteinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674860679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674860679069716748606796971674860679

GMDN Terms#

Term, Definition table
TermDefinition
Low density lipoprotein (LDL) cholesterol 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 low density lipoprotein (LDL) cholesterol lipid 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
06935740725705Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740725712Blood Lipid AnalyzerUrit Medical Electronic Co., Ltd.MRR2026-06-03
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.MRR2024-07-12
10673486002010Teco Diagnostics Direct LDL Cholesterol Reagent SetTECO DIAGNOSTICSMRR2023-11-13
06971674860587BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860594BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860600BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860617BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860624BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860631BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860648BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860655BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860662BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860686BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860693BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860709BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860716BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860723BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860730BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860747BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860754BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
06971674860761BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MRR2023-07-12
05055273213966DIRECT LDL-CHOLESTEROL (LDL)RANDOX LABORATORIES LIMITEDMRR2022-10-04
00817302024142CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT AU-661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024227CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT BL661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024487CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT DT661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00817302024623CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT ST661CAROLINA LIQUID CHEMISTRIES CORPORATIONMRR2022-08-19
00630414611037Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08
00630414305073Atellica CH LDLCSiemens Healthcare Diagnostics Inc.MRR2022-07-08
07350108630139Mercodia Oxidized LDL ELISAMercodia ABMRR2021-09-01