FDA.reportPublic FDA data

Antiserum to Human Albumin

Primary DI
B1761140
Brand
Antiserum to Human Albumin
Company
KENT LABORATORIES INC
Model
1
Catalog number
114002
Device description
Goat antiserum to Human Albumin
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
DCFAlbumin, Antigen, Antiserum, Control

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1761140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Albumin 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 albumin 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
00630414611099Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
00630414320298Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
04050598163300Albumin ELISAImmundiagnostik AGDCF2023-06-21
03610230007235Yumizen C1200 Albumin U/CSFHORIBA ABX SASDCF2020-09-14
00628063401116MicroalbuminSEKISUI DIAGNOSTICS, LLCDCF2019-10-02
06970291985222Microalbuminuria Kit (Immunoturbidimetric Method)Medicalsystem Biotechnology Co., Ltd.DCF2019-03-07
00386100002213UALB Reagent KitMEDICA CORPORATIONDCF2019-02-14
00817274022788JAS DiagnosticsDREW SCIENTIFIC, INC.DCF2018-07-24
00817274022795JAS DiagnosticsDREW SCIENTIFIC, INC.DCF2018-07-24
B24224MABHUE010Microalbumin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DCF2018-01-16
03610230008232ABX Pentra Micro ALB 2 CalHORIBA ABX SASDCF2017-07-07
03610230008225ABX Pentra Micro ALBUMIN 2 CPHORIBA ABX SASDCF2017-06-27
05051700018432Optilite Low Level Albumin KitTHE BINDING SITE GROUP LIMITEDDCF2017-06-07
15099590010645AUBECKMAN COULTER IRELAND INC.DCF2016-09-24
15099590020422AUBeckman Coulter, Inc.DCF2016-09-24
15099590670108AUBeckman Coulter, Inc.DCF2016-09-24
05051700010689Human Albumin NL BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700016193Human Albumin CSF Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700017916Optilite Albumin KitTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
05051700017923Human Microalbumin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDCF2016-09-24
00842768005312Dimension® Flex® reagent cartridge MALBSiemens Healthcare Diagnostics Inc.DCF2016-09-24
00842768006098DImension Vista® sALB Flex® reagent cartridgeSpecialty AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768006203DImension Vista® Microalbumin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768038013N Antiserum to Human AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00842768038020N Antiserum to Human AlbuminSiemens Healthcare Diagnostics Products GmbHDCF2016-09-24
00657498000434Albumin LiquiColor®STANBIO LABORATORY, L.P.DCF2016-09-23
00657498001516Sirrus® Albumin LiquiColor®STANBIO LABORATORY, L.P.DCF2016-09-23
04015630924899Tinaquant Albumin Gen2Roche Diagnostics GmbHDCF2016-09-20
00628063400812MICROALBUMIN AssaySEKISUI DIAGNOSTICS, LLCDCF2016-09-20
00816426020139K-ASSAY® Microalbumin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDCF2016-09-16