FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674867654
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:100mL×1 R2:20mL×1
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
KTOReagent, Immunoassay, Igg

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTOReagent, Immunoassay, IggImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674867654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674867654069716748676546971674867654

GMDN Terms#

Term, Definition table
TermDefinition
Human immunoglobulin G (IgG) animal conjugate antibody reagent IVDOne or multiple immunoglobulins sourced from an animal (e.g., goat, sheep, mouse, rabbit) intended to be used in combination with other IVDs for the qualitative and/or quantitative detection of antihuman immunoglobulin G (IgG) antibodies. The immunoglobulin molecules are conjugated or bound by additional substances (e.g., fluorescent markers, peroxidase enzymes) for the detection of immune complexes in clinical specimens.

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
05411967001347SpermMar Test IgA - complete kitFertipro NVKTO2026-05-06
06971674867609BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867616BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867623BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867630BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867647BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867661BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
06971674867906BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KTO2023-07-24
05411967002542SpermMar Test IgG - single kitFertipro NVKTO2019-12-11
05411967002559SpermMar Test IgG - single kitFertipro NVKTO2019-12-11
05411967001354SpermMar Test IgG - Complete kitFertipro NVKTO2019-02-01
54119670013546SpermMar Test IgG - Complete kitFertipro NVKTO2019-02-01
05411967000036SpermMar Test IgG - single kitFertipro NVKTO2018-08-22
05411967001361SpermMar IgG Negative ControlFertipro NVKTO2018-08-22
05411967001378SpermMar IgG Positive ControlFertipro NVKTO2018-08-22
05411967002566SpermMar Test IgA - single kitFertipro NVKTO2018-08-22
54119670000294SpermMar Test IgA - single kitFertipro NVKTO2018-08-22
54119670000362SpermMar Test IgG - single kitFertipro NVKTO2018-08-22
54119670013614SpermMar IgG Negative ControlFertipro NVKTO2018-08-22
54119670013782SpermMar IgG Positive ControlFertipro NVKTO2018-08-22