FDA.reportPublic FDA data

Alpha2-Macroglobulin

Primary DI
05415168003476
Brand
Alpha2-Macroglobulin
Company
Diagam
Model
08240396190
Catalog number
08240396190
Device description
Quantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on cobas c501/502 systems.
Published
2020-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEBAlpha-2-Macroglobulin, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415168003476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415168003476054151680034765415168003476

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of alpha-2-macroglobulin in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
374384030
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415168006873Alpha2-macroglobulin09029524190090295241902021-12-07
05415168004763Alpha2-Macroglobulin Serum CONT KIT08240426190082404261902020-01-08
05415168004770Alpha2-Macroglobulin CAL KIT08240400190082404001902020-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971674869948BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DEB2023-07-24
06971674869955BIOBASEBiobase Biodustry(Shandong)Co., Ltd.DEB2023-07-24
04050598000872α2-Makroglobulin ELISAImmundiagnostik AGDEB2023-06-21
04050598166103α2-Makroglobulin ELISAImmundiagnostik AGDEB2023-06-21
05415168006873Alpha2-macroglobulinDiagamDEB2021-12-07
B1761240Antiserum to Human Alpha 2 MacroglobulinKENT LABORATORIES INCDEB2016-09-24
05051700016469Human alpha 2 macroglobulin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDEB2016-09-24
05051700017480Optilite Alpha-2-macroglobulin KitTHE BINDING SITE GROUP LIMITEDDEB2016-09-24
00842768024412Dimension Vista® Flex® reagent cartridge A2MACSiemens Healthcare Diagnostics Products GmbHDEB2016-09-24
00842768029967N Antiserum to Human a2-MacroglobulinSiemens Healthcare Diagnostics Products GmbHDEB2016-09-24
15099590224059IMMAGEBeckman Coulter, Inc.DEB2016-08-24