FDA.reportPublic FDA data

Antiserum to Human Fibrinogen

Primary DI
B1761070
Brand
Antiserum to Human Fibrinogen
Company
KENT LABORATORIES INC
Model
1
Catalog number
107002
Device description
Goat antiserum to Human Fibrinogen
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
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1761070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093642254
Device count
1
Premarket exempt
true
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
B1761520Antiserum to Apolipprotein B11520022016-09-24
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

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