Mercodia Oxidized LDL Elisa

The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma.…

Registry build 21.09.26

The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

3manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (1), Guangxi (1), Hebei (1).

Chinese manufacturers registered for FDA product code MRR
Manufacturer City Province Registered as Device types
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70
Urit Medical Electronic Co., Ltd. Guilin Guangxi Contract manufacturer 28
Shijiazhuang Hipro Biotechnology Co., Ltd. Shijiazhuang Hebei Manufacturer 22

Record

Regulatory record for Mercodia Oxidized LDL Elisa
Listed by Mercodia AB, Sweden
FDA product code MRR
Device type System, Test, Low Density, Lipoprotein
Device class Class 1
Regulation 21 CFR 862.1475
Establishment Manufacturer
Premarket notification Exempt
Record published 2020-04-08
Record revised 2023-02-28 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C
Distribution end date 2023-02-28

Catalogue Numbers

Catalogue numbers for Mercodia Oxidized LDL Elisa
Catalogue number Size Status
10-1143-01 In distribution
10-1143-01 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biobase Biobase Biodustry(Shandong)Co., Ltd. 19
Carolina Liquid Chemistries Corp.® LDL Cholesterol Direct Reagent KIT DT661 Carolina Liquid Chemistries 4
Pointe Scientific, Inc. Horiba Instruments Incorporated 3
Direct LDL-Cholesterol (LDL) Randox Laboratories Limited 3
Pointe autoLDL Cholesterol Reagent Horiba Instruments Incorporated 2
N-geneous LDL-ST Cholesterol Reagent (R1) Sekisui Diagnostics, LLC 2
ACE Alfa Wassermann 2
N-geneous LDL-ST Cholesterol Reagent (R2) Sekisui Diagnostics, LLC 2
Advia® Chemistry Direct LDL Cholesterol Reagents Siemens Healthcare Diagnostics Inc 1
MedTest Dx, Inc. autoLDL Medtest DX 1
Pointe Scientific, Inc. autoLDL Cholesterol Horiba Instruments Incorporated 1
Dimension® Flex® reagent cartridge Aldl Siemens Healthcare Diagnostics Inc 1

Showing 12 of 26. All products under System, Test, Low Density, Lipoprotein

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer