Colorimetry, Cholinesterase

Which Manufacturers in China Make This?

One manufacturer in China holds an FDA registration for this device type, based in Shandong.

Biobase Biodustry(Shandong)Co., Ltd. Shandong

How Is DIH Classified?

Colorimetry, Cholinesterase is FDA product code DIH, Class 1, 21 CFR 862.3240.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 5 recalls under this product code since 2013. None was by a company in China. The root cause the FDA records most often is Equipment maintenance (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Colorimetry, Cholinesterase

AU

Cholinesterase

Colorimetry, Cholinesterase

Teco Diagnostics Cholinesterase Reagent Set

Teco Diagnostics Cholinesterase Reagent Set is used for in vitro diagnostic use in the quantitative kinetic determination of cholinesterase in human serum, plasma, or whole blood.

Colorimetry, Cholinesterase

Atellica CH Cholinesterase_2

Cholinestrase (CHE_2) Atellica CH

Colorimetry, Cholinesterase

Cholinesterase

Catalogue number 11877763216, listed by Roche Diagnostics Gmbh, Germany, under Colorimetry, Cholinesterase. 1 manufacturer in China is registered for this product code.

Colorimetry, Cholinesterase

Atellica CH CHE

Cholinestrase (CHE) Atellica CH - RGT 270T

Colorimetry, Cholinesterase

Test-Mate ChE Cholinesterase Test System

For the quantitative determination of Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians only.…

Colorimetry, Cholinesterase

PChE Assay Kit

For the quantitative determination of Plasma Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory technicians…

Colorimetry, Cholinesterase

Arena Star

Catalogue number Arum-WR-28-C2, listed by Arum Dentistry Co., Ltd., South Korea, under Colorimetry, Cholinesterase. 1 manufacturer in China is registered for this product code.

Colorimetry, Cholinesterase

Butyryl Cholinesterase (CHE)

2 catalogue numbers from CE7944, listed by Randox Laboratories Limited, United Kingdom, under Colorimetry, Cholinesterase. 1 manufacturer in China is registered for this product code.

Colorimetry, Cholinesterase

Cholinesterase Gen.2

2 catalogue numbers from 08105561190, listed by Roche Diagnostics Gmbh, Germany, under Colorimetry, Cholinesterase. 1 manufacturer in China is registered for this product code.

Colorimetry, Cholinesterase

AChE Assay Kit

For the quantitative determination of Erythrocyte Cholinesterase in whole blood to monitor pesticide exposure. For in vitro diagnostic use. For laboratory use by trained laboratory…

Colorimetry, Cholinesterase

Dimension Vista® Flex® Reagent Cartridge Pche

Pseudocholinesterase Flex® reagent cartridge, 160 tests

Colorimetry, Cholinesterase

Advia® Chemistry CHE Cholinesterase Reagents

PCHE - ADVIA Chem. - RGT - 4x234 tests

Colorimetry, Cholinesterase

Vitros

VITROS Chemistry Products CHE Slides

Colorimetry, Cholinesterase

Biobase

13 catalogue numbers from R1:50mL×2 R2:10mL×2, listed by Biobase Biodustry(Shandong)Co., Ltd., China, under Colorimetry, Cholinesterase. 1 manufacturer in China is registered for this product code.

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