FDA.reportPublic FDA data

Antiserum to Human IgE (epsilon specific)

Primary DI
B1761040
Brand
Antiserum to Human IgE (epsilon specific)
Company
KENT LABORATORIES INC
Model
1
Catalog number
104002
Device description
Goat antiserum to Human IgE
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
DGCIge, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DGCIge, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1761040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin E (IgE total) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870024400IgE-XR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2024-09-13
00850054026477QMedix™Diagnostic Automation, Inc.DGC2024-01-31
00380740153700AlinityABBOTT LABORATORIESDGC2023-10-14
04048474017885Immunoglobulin E (IgE) ELISADRG Instruments Gesellschaft mit beschränkter HaftungDGC2023-08-26
15099590701727Total Immunoglobulin E (IgE)Beckman Coulter, Inc.DGC2022-05-03
00840239017888Immunoglobulin E (IgE) ELISADRG International IncDGC2021-06-07
00380740156282ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156367ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00380740156404ARCHITECTABBOTT LABORATORIESDGC2020-03-03
00850392007350BioCheck IgE EIA Test KitBIOCHECK, INC.DGC2019-10-08
07333066019864ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066000664ImmunoCAP Total IgE Conjugate 400Phadia ABDGC2019-03-29
07333066019772ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066019789ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066019796ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066000206ImmunoCAP Total IgE Conjugate 100Phadia ABDGC2019-03-28
07333066000220ImmunoCAP Total IgE Curve Control StripPhadia ABDGC2019-03-28
07333066000367ImmunoCAP Total IgE Calibrator StripPhadia ABDGC2019-03-28
07333066019512ImmunoCAP Total IgE CalibratorsPhadia ABDGC2019-03-26
07333066019529ImmunoCAP Total IgE Curve ControlsPhadia ABDGC2019-03-26
07333066019642ImmunoCAP Total IgE Control LMHPhadia ABDGC2019-03-26
07333066019673ImmunoCAP Total IgEPhadia ABDGC2019-03-26
00816870020242IgE AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DGC2019-02-11
00816870020259Monobind AccuBind IgE ELISA Kit - 192 WellsMONOBIND, INC.DGC2019-02-11
00816870020266IgE AccuBind ELISA Test System - 480 WellsMONOBIND, INC.DGC2019-02-11
00816870020273IgE AccuBind ELISA Test System - 960 WellsMONOBIND, INC.DGC2019-02-11
00816870021928Monobind AccuLite IgE CLIA Kit - 96 WellsMONOBIND, INC.DGC2019-02-11
00816870021935IgE AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DGC2019-02-11
00816870021942IgE AccuLite CLIA Test System - 480 WellsMONOBIND, INC.DGC2019-02-11
00816870021959IgE AccuLite CLIA Test System - 960 WellsMONOBIND, INC.DGC2019-02-11