MedTest DX Lactate Dehydrogenase / BS480

Lactate Dehydrogenase, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum using the Mindray BS-480 analyzer. Size: 4 x 40 ml, 4 x 10 ml.

Registry build 21.09.26
2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CFJ
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70

Record

Regulatory record for MedTest DX Lactate Dehydrogenase / BS480
Listed by Medtest DX, United States
FDA product code CFJ
Device type Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device class Class 2
Regulation 21 CFR 862.1440
Record published 2016-09-27
Record revised 2025-09-24 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C
Distribution end date 2025-09-23

Catalogue Numbers

Catalogue numbers for MedTest DX Lactate Dehydrogenase / BS480
Catalogue number Size Status
LDH480 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biobase Biobase Biodustry(Shandong)Co., Ltd. 13
Pointe Scientific, Inc. Horiba Instruments Incorporated 10
JAS Diagnostics Drew Scientific, Ltd. 8
Synermed® Infrared Laboratory Systems LLC 7
Synchron Beckman Coulter, Inc. 4
Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix Teco Diagnostics 3
Lactate dehydrogenase liquid acc to Ifcc Roche Diagnostics Gmbh 3
Alinity Abbott Ireland 2
LDH L-P Randox Laboratories Limited 2
Lactate Dehydrogenase acc. to Ifcc ver.2 Roche Diagnostics Gmbh 2
LDH P-L Randox Laboratories Limited 2
Architect Abbott Medical 2

Showing 12 of 60. All products under Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase

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