FDA.reportPublic FDA data

α2-Makroglobulin ELISA

Primary DI
04050598000872
Brand
α2-Makroglobulin ELISA
Company
Immundiagnostik AG
Model
K 6610A
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04050598000872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050598000872040505980008724050598000872

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-2-macroglobulin 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 quantitative measurement of alpha-2-macroglobulin in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321663841
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
04050598163300Albumin ELISAK 63302023-06-21
04050598008540IDK® Pancreatic Elastase ELISAK 6915.20.US2023-06-21
04050598010420IDK® Pancreatic Elastase ELISAK 6915.US2023-06-21
04050598169906Chymotrypsin ActivityK 69902023-06-21
04050598000445Lysozyme ELISAK 69012023-06-21
04050598000452Lysozyme ELISAK 69022023-06-21
04050598000469Lysozyme ELISAK 69032023-06-21
04050598007673IDK® sIgA ELISAK 8870.20.US2023-06-21
04050598010406Lactoferrin ELISAK 6870.US2023-06-21
04050598010413Lactoferrin ELISAK 6870.20.US2023-06-21
04050598010437ox-LDL ELISAK 7810.US2023-06-21
04050598010444ox-LDL ELISAK 7810.20.US2023-06-21
04050598010451IDK® sIgA ELISAK 8870.US2023-06-21
04050598010468IDK Extract®K 6999.US2023-06-21
04050598010475Stool preparation system SASK 6998SAS.US2023-06-21
04050598010482Stool preparation system SASK 6998SAS.20.US2023-06-21
04050598010499Retinol-binding protein RBP/RBP4 ELISAK 6110.US2023-06-21
04050598010505Retinol-binding protein RBP/RBP4 ELISAK 6110.20.US2023-06-21
04050598010512IDK Extract®K 6999.17.US2023-06-21
04050598010529IDK Extract®K 6999.20.US2023-06-21

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
04050598166103α2-Makroglobulin ELISAImmundiagnostik AGDEB2023-06-21
05415168006873Alpha2-macroglobulinDiagamDEB2021-12-07
05415168003476Alpha2-MacroglobulinDiagamDEB2020-01-08
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