Calibrator for Red-Cell and White-Cell Counting

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are based in Guangdong and Jilin: 2 hold an FDA registration.

Dirui Industrial Co., Ltd. Jilin, contract manufacturer
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong

What Is FDA Product Code KSA?

Calibrator For Red-Cell And White-Cell Counting is FDA product code KSA, Class 2, 21 CFR 864.8185.

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.

Calibrator For Red-Cell And White-Cell Counting

ABX Minocal

Catalogue number 5300100300, listed by Horiba ABX SAS, France, under Calibrator For Red-Cell And White-Cell Counting. 2 manufacturers in China are registered for this product code.

Calibrator For Red-Cell And White-Cell Counting