FDA.reportPublic FDA data

Antiserum to Alpha 1 Antitrypsin

Primary DI
B1761220
Brand
Antiserum to Alpha 1 Antitrypsin
Company
KENT LABORATORIES INC
Model
1
Catalog number
122002
Device description
goat antiserum to Human Alpha 1 Antitrypsin
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
DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEMAlpha-1-Antitrypsin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1761220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-antitrypsin (protease inhibitor) 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-antitrypsin (protease inhibitor) 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
05051700010696Human Alpha 1 Antitrypsin NL BINDARID™ KitTHE BINDING SITE GROUP LIMITEDDEM2023-06-29
07613336130230Tina-quant a1-Antitrypsin ver.2Roche Diagnostics GmbHDEM2020-03-05
00380740156299ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156374ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156411ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740153519AlinityABBOTT LABORATORIESDEM2019-01-04
00630414596228Atellica CH AATSiemens Healthcare Diagnostics Inc.DEM2017-12-19
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONDEM2016-12-19
15099590010607AUBECKMAN COULTER IRELAND INC.DEM2016-09-24
05051700016421Human alpha 1 antitrypsin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
05051700017763Optilite Alpha-1-antitrypsin KitTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
00842768005992Dimension Vista®a1-Antitrypsin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00842768009921N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00842768009938N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00630414517728ADVIA® Chemistry AAT Alpha-1-Antitrypsin ReagentsSiemens Healthcare Diagnostics Inc.DEM2016-09-24
04015630916597Tinaquant 1Antitrypsin ver2Roche Diagnostics GmbHDEM2016-09-20
04015630928415Tinaquant 1Antitrypsin ver2Roche Diagnostics GmbHDEM2016-09-20
04015630927562Albumin BCPRoche Diagnostics GmbHDEM2016-09-20
04015630906758Tina-quant alpha1-AntitrypsinRoche Diagnostics GmbHDEM2016-09-20
00816426020009K-ASSAY® Alpha-1 AT ReagentKAMIYA BIOMEDICAL COMPANY, LLCDEM2016-09-16
00380740030131ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740044862ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740054151ARCHITECTABBOTT LABORATORIESDEM2016-09-09
15099590224042IMMAGEBeckman Coulter, Inc.DEM2016-08-24
10758750002290VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DEM2016-08-23