Hematology › Reagents

Who Makes It in China?

14 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Jilin, Shandong and Guangdong, and 4 other provinces. 1 of them is a contract manufacturer. Chinese manufacturers are registered for 12 of 24 device types here.

None of those device types needs a premarket submission before sale in the United States. The FDA has recorded 51 recalls across the section’s product codes; the root causes it names most often are Nonconforming Material/Component (9), Process control (6) and Material/Component Contamination (5).

The Largest Device Types Made in China

The device types with the most Chinese manufacturers are Diluent, Blood Cell (5), Calibrator For Cell Indices (3), Material, Quality Control, Semen Analysis (3), Mixture, Hematology Quality Control (3) and Products, Red-Cell Lysing Products (3). All 12 device types in this section with a Chinese manufacturer, most manufacturers first:

Diluent, Blood Cell 5 manufacturers
Calibrator For Cell Indices 3 manufacturers
Material, Quality Control, Semen Analysis 3 manufacturers
Mixture, Hematology Quality Control 3 manufacturers
Products, Red-Cell Lysing Products 3 manufacturers
Calibrator For Hemoglobin And Hematocrit Measurement 2 manufacturers
Calibrator For Platelet Counting 2 manufacturers
Calibrator For Red-Cell And White-Cell Counting 2 manufacturers
Control, Hemoglobin 2 manufacturers
Control, Cell Counter, Normal And Abnormal 1 manufacturer
Control, Hematocrit 1 manufacturer
Mixture, Control, White-Cell And Red-Cell Indices 1 manufacturer

Products, Red-Cell Lysing Products

Coulter HmX Pak Reagent Kit

Catalogue number 8547166, listed by Beckman Coulter, Inc., United States, under Products, Red-Cell Lysing Products. 3 manufacturers in China are registered for this product code.

Control, Hemoglobin

DiaSpect Control Pack HBT3

Catalogue number 90B.0013, listed by DiaSpect Medical GmbH, under Control, Hemoglobin. 2 manufacturers in China are registered for this product code.

Control, Hematocrit

ChemSTAT Hematocrit Evaluator 3

ChemSTAT Hematocrit Evaluator 3, 10 ampoules x 1.8 mL

Products, Red-Cell Lysing Products

Medonic M51-L2 Lyse

The reagents are accessories intended to be used in combination with the Medonic M51. The lyse reagents lyses the red blood cells and maintain the morphology of white blood cells enabling…

Products, Red-Cell Lysing Products

ABX Alphalyse (360ml)

Catalogue number 1210906014, listed by Horiba ABX SAS, France, under Products, Red-Cell Lysing Products. 3 manufacturers in China are registered for this product code.

Mixture, Hematology Quality Control

Flow-SET

Flow-Set Fluorospheres

Control, Hemoglobin

Aimstrip Hemoglobin Control SET

Intended to validate hemoglobin testing using the AimStrip® HB Hemoglobin Testing System.

Diluent, Blood Cell

Poch-Pack D

Diluent for the pocH-100i hematology analyzer

Products, Red-Cell Lysing Products

Diatro•Diff-5P

Diatro•Diff-5P WBC differentiation reagent is a stabilized and micro-filtered reagent for quantitative determination of leukocytes (WBC) and leukocyte 5-part differentiation (LYM, MONO,…

Diluent, Blood Cell

M-30D Diluent

Catalogue number M-30D, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Diluent, Blood Cell. 5 manufacturers in China are registered for this product code.

Control, Hemoglobin

Hemochroma Plus Control

hemochroma PLUS Controls are intended for use as quality control material to assure the validity and performance of the hemochroma PLUS System in measuring the human hemoglobin…

Control, Hemoglobin

DiaSpect Control HBT3

Catalogue number 7049-6213, listed by EKF Diagnostic Gmbh, Germany, under Control, Hemoglobin. 2 manufacturers in China are registered for this product code.

Control, Hemoglobin

Dade® Sickle-Trol Hemoglobin Controls

For testing for the presence of hemoglobin S in solubility tests and hemoglobing electrophoresis

Products, Red-Cell Lysing Products

Coulter Ac•T 5diff Fix

COULTER AcT 5diff Fix

Diluent, Blood Cell

Lumipulse G Specimen Diluent 1

Catalogue number 231203, listed by Fujirebio Inc., Japan, under Diluent, Blood Cell. 5 manufacturers in China are registered for this product code.

Diluent, Blood Cell

Atellica IM Multi-Diluent 2

Multi-Diluent 2 Atellica IM - CONS (2 PK) 1 x 10mL

Mixture, Hematology Quality Control

Advia® 120/2120/2120i TESTpoint CSF Control Kit

ADVIA®120/2120/2120i TESTpoint™ CSF Control Kit

Diluent, Blood Cell

Coulter Ac•T 5diff Diluent

COULTER AcT 5diff Diluent (20 L)

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.

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