FDA.reportPublic FDA data

Albumin ELISA

Primary DI
04050598163300
Brand
Albumin ELISA
Company
Immundiagnostik AG
Model
K 6330
Published
2023-06-21
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
04050598163300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050598163300040505981633004050598163300

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of albumin in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used for the detection of small amounts of albumin in urine as an indicator of a kidney disease known as moderately increased albuminuria or microalbuminuria.

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
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
04050598000872α2-Makroglobulin ELISAK 6610A2023-06-21
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
00630414611099Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
00630414320298Atellica CH Urine Albumin (UAlb)Siemens Healthcare Diagnostics Inc.DCF2025-08-11
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
00816426020139K-ASSAY® Microalbumin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDCF2016-09-16