Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2647876

FEI Number

2647876

Entity Name

BECTON DICKINSON CARIBE LTD.

City/State/Country

CAYEY, PR, US

Establishment Address

VICKS DR., LOT No. 6, CAYEY, PR 00737, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173873

PMA Number

N/A

All Registered Proprietary Names

BD BBL Sensi-Disc Tigecycline 15 µg BD BBL Sensi-Disc Fosfomycin 200 ?g BD BACTEC Plus Anaerobic/F Culture Vials BD BACTEC Myco/F Lytic Culture Vials BD BBL Sensi-Disc Ticarcillin/Clavulanic Acid 75/10 ?g BD Affirm VPIII Microbial Identification Test BD BBL Sensi-Disc Ceftaroline 30 ?g BD BBL Sensi-Disc Amoxicillin/Clavulanic Acid 20/10 ?g BD BBL Sensi-Disc Ceftazidime/Clavulanic Acid 30/10 ?g BD BBL Sensi-Disc Cefotaxime/Clavulanic Acid 30/10 ?g BD BBL Sensi-Disc Norfloxacin 10 ?g BD AffirmVPIII Microbial Identification Test BD BBL Sensi-Disc Clarithromycin 15 ?g BD BBL Sensi-Disc Ceftazidime 30 ?g BD BBL Sensi-Disc Cefixime 5 ?g BD BBL Sensi-Disc Aztreonam 30 µg BD BBL Sensi-Disc Moxifloxacin 5 ?g BD BBL Sensi-Disc Azithromycin 15 ?g BD BBL Sensi-Disc Cefaclor 30 ?g BD BACTEC Platelet Aerobic/F Culture Vials BD BACTEC Platelet Anaerobic/F Culture Vials BD BACTEC Lytic/10 Anaerobic/F Culture Vials BD BBL Sensi-Disc Trimethoprim 5 µg BD BBL Ninhydrin Reagent Droppers BD BBL DMACA Indole Reagent Droppers BD BBL Cefinase BD BBL DrySlide PYR Kit BD BBL Methylene Blue Loeffler Stain Droppers BD BBL Taxo TB Niacin Test Strips BD BBL Voges-Proskauer A Reagent Droppers BD BBL Catalase Reagent Droppers BD BBL DrySlide Oxidase BD BBL Nitrate B Reagent Droppers BD BBL Taxo Novobiocin BD BBL Taxo A BD BBL Taxo SPS BD BBL 10% Potassium Hydroxide Reagent Droppers BD BBL Taxo ONPG BD BBL Taxo X BD BBL Taxo Kanamycin 1 mg BD BBL TAXO Blank Paper Discs BD BBL Ferric Chloride Reagent Droppers BD BBL Nitrate A Reagent Droppers BD BBL DrySlide Indole BD BBL Voges-Proskauer B Reagent Droppers BD BBL Taxo VX BD BBL Taxo Anaerobe Differentiation Discs Set BD BBL Taxo Hippurate BD BBL Blank Paper Discs, 6mm diameter BD BBL Oxidase Reagent Droppers BD BBL Taxo P BD BBL Taxo V BD BBL Desoxycholate Reagent Droppers BD BBL Indole Reagent Droppers BD BBL Dryslide Nitrocefin BD BBL PYR Reagent Droppers BD GasPak EZ Campy Gas Generating Pouch System BD BBL Dry Anaerobic Indicator Strips BD GasPak EZ Campy Container System Sachets BD Bio-Bag Type C BD GasPak EZ Anaerobe Gas Generating Pouch System with Indicator BD GasPak EZ Anaerobe Container System Sachets with Indicator BD GasPak EZ Small Incubation Container BD GasPak EZ Large Incubation Container BD GasPak EZ Anaerobe Container System Sachets BD GasPak EZ Standard Incubation Container BD BBL CO2 Indicators BD CO2 Gas Generators BD GasPak EZ CO2 Gas Generating Pouch System BD GasPak EZ CO2 Container System Sachets BD BBL Sensi-Disc Piperacillin 100 ?g BD BBL Sensi-Disc Ceftazidime/Avibactam 30/20 ?g BD BBL Sensi-Disc Ceftriaxone 30 ?g BD BBL Sensi-Disc Linezolid 30 ?g BD BBL Sensi-Disc Doripenem 10 ?g BD Affirm VPIII Sample Collection Sets BD Affirm VPIII Ambient Temperature Transport System BD Affirm VPIII Sample Collection Swabs BD BBL Sensi-Disc Oxacillin 1 ?g BD BBL Sensi-Disc Gentamicin 10 ?g BD BBL Sensi-Disc Amikacin 30 ?g BD BBL Sensi-Disc Ampicillin 10 ?g BD BBL Sensi-Disc Tetracycline 30 ?g BD BBL Sensi-Disc Colistin 10 ?g BD BBL Sensi-Disc Vancomycin 5 ?g BD BBL Sensi-Disc Neomycin 30 ?g BD BBL Sensi-Disc Nalidixic Acid 30 ?g BD BBL Sensi-Disc Erythromycin 15 ?g BD BBL Sensi-Disc Oxytetracycline 30 µg BD BBL Sensi-Disc Kanamycin 30 ?g BD BBL Sensi-Disc Penicillin 10 units BD BBL Sensi-Disc Cefoxitin 30 ?g BD BBL Sensi-Disc Novobiocin 5 µg BD BBL Sensi-Disc Doxycycline 30 ?g BD BBL Sensi-Disc Clindamycin 2 ?g BD BBL Sensi-Disc Cephalothin 30 ?g BD BBL Sensi-Disc Rifampin 5 ?g BD BBL Sensi-Disc Polymyxin B 300 units BD BBL Sensi-Disc Streptomycin 10 ?g BD BBL Sensi-Disc Tobramycin 10 ?g BD BBL Sensi-Disc Nitrofurantoin 300 ?g BD BBL Sensi-Disc Chloramphenicol 30 ?g BD BBL Sensi-Disc Bacitracin 10 units BD BBL Sensi-Disc Bacitracin 2 units BD BBL Sensi-Disc Nitrofurantoin 100 ?g BD BBL Sensi-Disc Trimethoprim/Sulfamethoxazole 1.25/23.75 µg BD BBL Sensi-Disc Vancomycin 30 ?g BD BBL Sensi-Disc Novobiocin 30 µg BD BACTEC Plus Aerobic/F Culture Vials BD BACTEC Myco/F Lytic Culture Vials BD BBL Sensi-Disc Cefoperazone 75 ?g BD BBL Sensi-Disc Ticarcillin 75 ?g BD BBL Sensi-Disc Cefuroxime 30 ?g BD BACTEC Peds Plus/F Culture Vials BD BACTEC Standard Anaerobic/F Culture Vials BD BBL Sensi-Disc Netilmicin 30 µg BD BACTEC Standard/10 Aerobic/F Culture Vials BD BACTEC Platelet Aerobic/F Culture Vials BD BACTEC Platelet Anaerobic/F Culture Vials BD BACTEC Peds Plus/F Culture Vials

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2001-08-28
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2014-12-11
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2014-07-09
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
MJM	Dna Probe, Gardnerella Vaginalis	Microbiology	Class 1	866.2660	1996-02-13
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2011-12-13
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
MLA	Dna Probe, Yeast	Microbiology	Class 1	866.2660	2008-07-16
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2019-03-05
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2013-05-23
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	Class 1	866.2660	2004-12-28
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2000-09-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2016-07-19
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-05
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-12-06
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2008-09-17
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2007-12-03
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2023-04-04
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2023-04-04
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2016-03-03
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-02-15
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	Class 2	866.1620	2007-11-30
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2017-02-15
MZC	System, Detection, Bacterial, For Platelet Transfusion Products	Microbiology	Class 1	866.2560	2023-09-19
MDB	System, Blood Culturing	Microbiology	Class 1	866.2560	2018-03-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Becton Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002664	Hardy Diagnostics	HARDYDISK LEVOFLOXACIN, 5MCG	2000-10-26
K770926	Analytical Products, Inc.	SUSPENSION SALINE, API 20E	1977-06-17
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0028-2014	Becton Dickinson & Co. BD Diagnostic Systems	1	BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Mycobacteria Growth Indicator Tube supplemented with Bactec MGIT Growth Supplement and BBL MGIT PANTA antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC MGIT 960 and BACTEC MGIT 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

Similar Registrations

Registration Number	Establishment Name	Location
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
8010096	OXOID, LTD.	BASINGSTOKE, HAMPSHIRE, GB
8020667	MAST GROUP LTD.	BOOTLE, MERSEYSIDE Liverpool, GB
2022807	HARDY DIAGNOSTICS	Orcutt, CA, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2647876. Last updated year: 2026. Please use registration number 2647876 when referencing this establishment in official correspondence.