FDA.reportPublic FDA data

ORTHO

Primary DI
10758750003754
Brand
ORTHO
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
718380
Catalog number
718380
Device description
ORTHO® Bovine Albumin Solution Polymerized Bovine Solution
Published
2016-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
10758750003754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000375410758750003754

GMDN Terms#

Term, Definition table
TermDefinition
Bovine serum albumin (BSA) immunohaematology reagent IVDA substance or reactant that is a bovine serum albumin (BSA) solution intended to be used in immunohaematological testing of a clinical specimen to enhance or potentiate red cell agglutination reactions by reducing the zeta potential of red blood cells.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068715424
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
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

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
B1761140Antiserum to Human AlbuminKENT LABORATORIES INCDCF2016-09-24
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