Turbidimetric Method, Lipoproteins

Who Makes This Device Type in China?

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

Zhejiang Orient Gene Biotech Zhejiang, contract manufacturer

How Is JHN Classified?

Turbidimetric Method, Lipoproteins is FDA product code JHN, Class 1, 21 CFR 862.1475.

How Does It Reach the US Market?

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 Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2025. None was by a company in China. The root cause the FDA records most often is Error in labeling (1).

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

Turbidimetric Method, Lipoproteins

Human Apolipoprotein B (Apo B) Kit for Use on Spaplus

Catalogue number NK086.S, listed by The Binding Site Group Ltd., United Kingdom, under Turbidimetric Method, Lipoproteins. 1 manufacturer in China is registered for this product code.

Turbidimetric Method, Lipoproteins

APO B

An APO B test system is a device intended for the quantitative in vitro determination of Apolipoprotein B (APO B) in serum and plasma.

Turbidimetric Method, Lipoproteins

Human Apolipoprotein A-1 (Apo A-1) Kit for Use on Spaplus

Catalogue number NK085.S, listed by The Binding Site Group Ltd., United Kingdom, under Turbidimetric Method, Lipoproteins. 1 manufacturer in China is registered for this product code.

Turbidimetric Method, Lipoproteins