FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674869313
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:20mL×4 R2:5mL×4
Published
2023-07-24
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
MGAAlpha-1 Microglobulin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGAAlpha-1 Microglobulin, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674869313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674869313069716748693136971674869313

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-microglobulin 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 qualitative and/or quantitative detection of alpha-1-microglobulin 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
04048474051001α1-Microglobulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungMGA2023-09-01
00840239051004a1-Microglobulin ELISADRG International IncMGA2023-08-25
06971674868064BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674868439BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674869306BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674869320BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674869337BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
00816426020283K-ASSAY® Alpha-1 Microglobulin ReagentKAMIYA BIOMEDICAL COMPANY, LLCMGA2016-09-16
00816426020603K-ASSAY® Urine Alpha-1 Microglobulin CalibratorKAMIYA BIOMEDICAL COMPANY, LLCMGA2016-09-16
00816426020610K-ASSAY® Serum / Plasma Alpha-1 Microglobulin CalibratorKAMIYA BIOMEDICAL COMPANY, LLCMGA2016-09-16
15099590180140IMMAGEBeckman Coulter, Inc.MGA2016-08-24
00889024198517NAZimmer, Inc.MGA2016-05-24