Calculator/Data Processing Module, for Clinical Use

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Zhejiang and Jiangsu, and 2 other provinces: 7 hold an FDA registration. 2 are contract manufacturers.

Acon Biotech (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
Dongguan BAO Kang Dian ZI KE JI Limited Guangdong, contract manufacturer
Foshan Zike Technology Co., Ltd. Guangdong
Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
Shanghai Bestcovered Limited Shanghai
Tianjin Empecs Medical Device Co., Ltd. Tianjin, contract manufacturer
Zhejiang Gene Science Co., Ltd. Zhejiang

What Is FDA Product Code JQP?

Calculator/Data Processing Module, For Clinical Use is FDA product code JQP, Class 1, 21 CFR 862.2100.

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 220 recalls under this product code since 2001. None was by a company in China. The root causes the FDA records most often are Software design (103), Device Design (25) and Software change control (9).

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

Calculator/Data Processing Module, For Clinical Use

Atellica Connect Test System

Catalogue number 11697146, listed by Siemens Healthcare Diagnostics Inc, United States, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

BD Kiestra™ Standard Connector

Catalogue number 446945, listed by BD Kiestra B.V., Netherlands, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

Wasp-FLO™ Conveyor

Catalogue number W091-010, listed by Copan Wasp, Italy, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

TDNexLabs

TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information. TDNexLabs is intended to be used only by health…

Calculator/Data Processing Module, For Clinical Use

B-Gate Interface

Catalogue number 06884750001, listed by Roche Diagnostics Gmbh, Germany, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

TDGenet

Patient-centric software for genetics laboratories - Tailor-made software for cytogenetics and molecular genetics laboratories, and for coordinating all clinical genetics activities.

Calculator/Data Processing Module, For Clinical Use

Cobas Infinity POC IT Solutions

Catalogue number 08739170001, listed by Roche Diagnostics Gmbh, Germany, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

Triton

Triton QBL

Calculator/Data Processing Module, For Clinical Use

BD Kiestra™ ErgonomicA Connector L

Catalogue number 446094, listed by BD Kiestra B.V., Netherlands, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

wtATTR-CM AcceleraTTR™

Software to identify heart failure patients who may be at risk of having wtATTR-CM

Calculator/Data Processing Module, For Clinical Use

GE

Catalogue number GP200, listed by Bionime Corporation, Taiwan, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

Navify POC Operations

Catalogue number 10170280001, listed by Roche Diagnostics Gmbh, Germany, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

FreeStyle Precision Pro

Catalogue number 72011-01, listed by Abbott Diabetes Care Limited, United Kingdom, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

Msms Workstation

The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.

Calculator/Data Processing Module, For Clinical Use

Alissa Interpret

Catalogue number K5849AA, listed by Agilent Technologies Singapore (International) Pte Ltd., Singapore, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

Atellica Connect

Catalogue number 11697144, listed by Siemens Healthcare Diagnostics Inc, United States, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.

Calculator/Data Processing Module, For Clinical Use

USB-Stick Magellan PRO V7.5

This Media contains V7.5 of the following registered Medical Devices: (DI)09120052070880 SOFTWARE MAGELLAN PRO V7.x, (DI)09120052070910 SOFTWARE MAGELLAN PRO TRACKER V7.x

Calculator/Data Processing Module, For Clinical Use

POC Controller

POC Controller is a software middleware intended for use by laboratory professionals in single-site and multi-site clinical laboratories performing in vitro diagnostic point-of-care…

Calculator/Data Processing Module, For Clinical Use

PatientCare

Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.

Calculator/Data Processing Module, For Clinical Use

OMNI-Lab

OMNI-Lab is a Laboratory Information System (LIS) intended to be used for the management of clinical information. The OMNI-Lab stand-alone software is only used by trained health…

Calculator/Data Processing Module, For Clinical Use

BD Kiestra™ Main Base

Catalogue number 446097, listed by BD Kiestra B.V., Netherlands, under Calculator/Data Processing Module, For Clinical Use. 7 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