QBC Diagnostics

Refurbished QBC STAR-I Centrifugal Hematology System, Biochem: Refurbished QBC STAR-I Analyzer - Biochem; QBC Disposable Starter Kit (20 STAR Tubes)

Registry build 21.09.26
3manufacturers in China registered for this device type
41catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GKZ
Manufacturer City Province Registered as Device types
VTech Communications Ltd Dongguan Guangdong Contract manufacturer 5
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
Onechipdx Biotech (Suzhou) Co., Ltd. Suzhou Jiangsu Specification developer 2

Record

Regulatory record for QBC Diagnostics
Listed by Drucker Diagnostics, LLC, United States
FDA product code GKZ
Device type Counter, Differential Cell
Device class Class 2
Regulation 21 CFR 864.5220
Establishment Remanufacturer, Complaint-file establishment, Manufacturer
510(k) K992849
Record published 2016-09-24
Record revised 2023-10-25 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for QBC Diagnostics
Catalogue number Size Per pack Status
42900209C In distribution
424450 In distribution
424347 In distribution
427762 In distribution
429625 100 In distribution
424330 In distribution
424333 In distribution
423406 100 In distribution
429001 In distribution
3406-300-000 20 In distribution
429576 In distribution
429578 In distribution
42900209 In distribution
253037 100 In distribution
429577 In distribution
429011 20 In distribution
424346 In distribution
4277-112-300 250 In distribution
42900109 In distribution
253005 2,000 In distribution
42857609 In distribution
424331 In distribution
424343 In distribution
424340 In distribution
424345 In distribution
427761 In distribution
427414 In distribution
427760 In distribution
428605 In distribution
424332 In distribution
42900109P In distribution
427400 In distribution
424350 In distribution
428000 In distribution
429002C In distribution
429609 In distribution
429002 In distribution
429001P In distribution
42957609 In distribution
427426 In distribution
429000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cell-DYN Abbott Laboratories 19
Research and Diagnostic Systems Research AND Diagnostic Systems, Inc. 17
Simultest Becton, Dickinson AND Company 10
BD FACSCanto™ Becton, Dickinson AND Company 10
FACSCanto Becton, Dickinson AND Company 7
BD Multitest Becton, Dickinson AND Company 6
Coulter AcT Beckman Coulter, Inc. 6
BD™ Multi-Check Becton, Dickinson AND Company 6
BD Tritest Becton, Dickinson AND Company 6
Coulter LH Beckman Coulter, Inc. 5
HemoScreen Pixcell Medical Inc. 5
Calibrite Becton, Dickinson AND Company 4

Showing 12 of 245. All products under Counter, Differential Cell

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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