FDA.reportPublic FDA data

ox-LDL ELISA

Primary DI
04050598010444
Brand
ox-LDL ELISA
Company
Immundiagnostik AG
Model
K 7810.20.US
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
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050598010444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050598010444040505980104444050598010444

GMDN Terms#

Term, Definition table
TermDefinition
Oxidized low density lipoprotein (OxLDL) 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 oxidized low density lipoprotein (OxLDL) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

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
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
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
00850053916250IDG/SanzayIDG/SANZAY CorporationLBS2024-06-25
00893038002890Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002913Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002920Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
00893038002937Cholestech LDX™Alere San Diego, Inc.LBS2023-12-20
04050598010437ox-LDL ELISAImmundiagnostik AGLBS2023-06-21
05055273201185DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
05055273208412DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
05055273208481DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2022-10-04
00630414610832Atellica CH HDLCSiemens Healthcare Diagnostics Inc.LBS2022-07-08
00630414305059Atellica CH HDLCSiemens Healthcare Diagnostics Inc.LBS2022-07-08
04015630926879HDL-Cholesterol plus 3rd generationRoche Diagnostics GmbHLBS2021-02-08
00630414508436ADVIA® Chemistry D-HDL Direct HDL Cholesterol ReagentsSiemens Healthcare Diagnostics Inc.LBS2020-09-24
00630414551784ADVIA® Chemistry D-HDL Direct HDL Cholesterol ReagentsSiemens Healthcare Diagnostics Inc.LBS2020-09-24
00630414596204Atellica™ CH D-HDLSiemens Healthcare Diagnostics Inc.LBS2020-09-24
10758750001668VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBS2020-04-18
10758750002825VITROSORTHO-CLINICAL DIAGNOSTICS, INC.LBS2020-04-18
00380740161484ARCHITECTAbbott GmbHLBS2020-03-21
07613336121306HDL-Cholesterol Gen.4Roche Diagnostics GmbHLBS2020-03-05
05055273208467DIRECT HDL-CHOLESTEROL (HDL)RANDOX LABORATORIES LIMITEDLBS2019-06-03
00386100002077HDL CHOL Reagent KitMEDICA CORPORATIONLBS2019-02-14
05055273201291HDLRANDOX LABORATORIES LIMITEDLBS2018-12-24
04015630942589HDL-Cholesterol Gen.4Roche Diagnostics GmbHLBS2018-12-07
00380740129989AlinityAbbott GmbHLBS2018-08-08
00380740129996AlinityAbbott GmbHLBS2018-08-08
00380740005313ARCHITECTABBOTT LABORATORIESLBS2018-07-31
00817274022252JAS DiagnosticsDREW SCIENTIFIC, INC.LBS2018-06-04
00852169008164ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBS2018-05-18
00852169008201ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) CholesterolCLEARCHEM DIAGNOSTICS INC.LBS2018-05-18
00857969006532ACEALFA WASSERMANN, INC.LBS2017-10-10