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Bd Biosciences

USA · San Jose

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

15listed device types

Class I 5Class II 9Class III 0unclassified 1

plus 52 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

24registered devices

Class I 19Class II 5

38 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class II 5Class III 2

30 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States52 registration records, 10 510(k), 0 PMA, 34 excluded

Brazil24 confirmed, 5 excluded

Canada7 confirmed, 3 excluded

Manufacturer names merged into this page: Becton, Dickinson and Company, BD Biosciences · BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES · BD Biosciences San Diego · BECTON, DICKINSON AND COMPANY BD BIOSCIENCES

FDA 510(k) clearances by year

22000

12004

22006

22007

12008

12009

12015

FDA listed device types

showing 8 of 15

Counter, Differential Cell 1Assay, T Lymphocyte Surface Marker 1Control, White-Cell 1Counter, Cell, Automated (Particle Counter) 1Assay, B Lymphocyte Marker 1Cytokeratins 1Flow Cytometric Reagents And Accessories. 1Mixture, Hematology Quality Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K141468	BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)	2015-02-27
US	K090967	BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611	2009-07-31
US	K081213	BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010	2008-08-14
BR	10033430176	BD FACS LYSING SOLUTION	Class I
BR	10033430901	Família BD Multi-Check Control	Class I
BR	10033430891	BD Trucount Tubes	Class II
CA	5925	RETIC-COUNT TEST KIT	Class II
CA	14330	SIMULTEST TEST KIT	Class III
CA	14331	FACSCOUNT SYSTEM	Class III

Bd Biosciences

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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