Who else makes this device?

Name: BD
Brand: BD

BD · Counter, Differential Cell → Hematology › Automated Hematology Devices

3manufacturers in China registered for this device type

1catalogue number

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 BD
Listed by	Becton, Dickinson AND Company, United States
FDA product code	GKZ
Device type	Counter, Differential Cell
Device class	Class 2
Regulation	21 CFR 864.5220
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
Record published	2018-01-10
Record revised	2024-10-14 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 25 °C
Distribution end date	2023-02-08

Catalogue Numbers

Catalogue numbers for BD
Catalogue number	Size	Status
663028		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
QBC Diagnostics	Drucker Diagnostics, LLC	41
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

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

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of BD
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Becton, Dickinson and Company, BD Biosciences	UDI-DI	2022-10-03	Class II	Under Investigation by firm	Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label d	11,709 tubes (corrected 11/04/2022)

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.

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