FDA.reportPublic FDA data

Antiserum to Apolipprotein B

Primary DI
B1761520
Brand
Antiserum to Apolipprotein B
Company
KENT LABORATORIES INC
Model
1
Catalog number
152002
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MSJApolipoproteins

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSJApolipoproteinsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850690000ANTISERUM TO HUMAN APOLIPOPROTEIN BKent Laboratories, Inc.1985-11-01MSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1761520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein B (Apo B) 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 apolipoprotein B (Apo B) lipid in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093642254
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1761250Antiserum to Human Transferrin11250022016-09-24
B1761254Transferrin RID plate package11254112016-09-24
B1761255Transferrin RID plate kit11255112016-09-24
B1761080Antiserum to Human Properdin11080022016-09-24
B1761082Anti Human Properdin FITC11082022016-09-24
B1761210Antiserum to Human C-3b Inactivator (factor I)11210022016-09-24
B1761212Anti Human C3b Inactivator FITC11212022016-09-24
B1761230Antiserum to Human Alpha 1 Acid Glycoprotein11230022016-09-24
B176131Antiserum to Human Myoglobin11310022016-09-24
B1761500Antiserum to Apolipoprotein A-111500022016-09-24
B1761540Antiserum to Human Prealbumin11540022016-09-24
B1761000Antiserum to Whole Human Serum11000022016-09-24
B1761010Antiserum to Human IgG (gamma chain specific)11010022016-09-24
B1761011Rhodamine conjugated antiserum to Human IgG11011022016-09-24
B1761012Anti Human IgG FITC11012022016-09-21
B1761014IgG RID Plate Package11014112016-09-24
B1761015IgG RID Plate Kit11015112016-09-24
B1761018Peroxidase conjugated Antiserum to Human IgG11018722016-09-24
B1761020Antiserum to Human IgA (alpha chain specific)11020022016-09-24
B1761021Rhodamine conjugated antiserum to Human IgA110210022016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06971674860785BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
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06971674860839BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
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06971674860853BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
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06971674860921BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860938BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860945BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860952BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
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06971674860976BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860983BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674860990BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20
06971674861003BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MSJ2023-07-20