Immunology & Microbiology › Tumor Antigen Test Systems

Who Makes It in China?

2 manufacturers in China hold an FDA registration for a device type in this section, based in Jiangsu. 1 of them is a contract manufacturer. Chinese manufacturers are registered for 2 of 36 device types here.

Every one of them needs a premarket submission before sale in the United States. The FDA has recorded 101 recalls across the section’s product codes; the root causes it names most often are Device Design (11), Error in labeling (8) and PMA (7).

The Largest Device Types Made in China

The device types with a Chinese manufacturer are Bcr/Abl1 Monitoring Test (1) and Next Generation Sequencing Based Tumor Profiling Test (1).

Bcr/Abl1 Monitoring Test 1 manufacturer
Next Generation Sequencing Based Tumor Profiling Test 1 manufacturer

Bcr/Abl1 Monitoring Test

Xpert BCR-ABL Ultra

Xpert BCR-ABL Ultra measures BCR-ABL1 RNA relative to ABL RNA in peripheral blood from patients with diagnosed Philadelphia chromosome positive chronic myeloid leukemia. It monitors…

Bcr/Abl1 Monitoring Test

QuantideX qPCR BCR-ABL IS Kit

QuantideX qPCR BCR-ABL IS Kit is a molecular assay kit for measuring BCR-ABL transcript levels using quantitative PCR. It targets the major BCR-ABL breakpoints associated with chronic…

Next Generation Sequencing Based Tumor Profiling Test

Geneseeqprime NGS Tumor Profiling Assay (Ffpe) Genesis by Geneseeq Software

Catalogue number GS6101, listed by Geneseeq Technology Inc., Canada, under Next Generation Sequencing Based Tumor Profiling Test. 1 manufacturer in China is registered for this product code.

Next Generation Sequencing Based Tumor Profiling Test

PGDx Elio™ Platform

Catalogue number B0110900, listed by Personal Genome Diagnostics Inc., United States, under Next Generation Sequencing Based Tumor Profiling Test. 1 manufacturer in China is registered for this product code.

Bcr/Abl1 Monitoring Test

MRDx BCR-ABL Test

The MRDx Test utilizes quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR) for BCR-ABL and ABL quantitation. The rapid, one-step protocol allows for both…

Next Generation Sequencing Based Tumor Profiling Test

Geneseeqprime NGS Tumor Profiling Assay (Ffpe)

Catalogue number GS6005, listed by Geneseeq Technology Inc., Canada, under Next Generation Sequencing Based Tumor Profiling Test. 1 manufacturer in China is registered for this product code.

Next Generation Sequencing Based Tumor Profiling Test

PGDx Elio™ Tissue Complete

PGDx elio tissue complete profiles tumor DNA from formalin-fixed, paraffin-embedded tissue in patients with previously diagnosed solid cancers. The assay combines reagent kits with analysis…

Next Generation Sequencing Based Tumor Profiling Test

PGDx Elio™ Server

PGDx elio server is a dedicated computer platform for analysis and reporting software used with the elio tissue complete CDx assay family. The server processes sequencing data in the elio…

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