Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008352382

FEI Number

3008352382

Entity Name

Becton Dickinson Caribe, LTD

City/State/Country

Cayey, PR, US

Establishment Address

Vicks Drive, Lot 1 Corner Road 735, Cayey, PR 00736, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

BD BBL Thioglycollate Medium without Indicator BD Difco Supplement C BD Difco Nitrate Broth BD BBL Casman Agar Base BD BBL SIM Medium BD BBL CLED Agar BD BBL Phytone Yeast Extract Agar BD BBL Trichosel Broth, Modified BD BBL Enterococcosel Agar BD Difco Tryptic Soy Broth without Dextrose BD BBL Hemoglobin Solution 2% BD Difco Egg Yolk Enrichment 50% BD BBL Middlebrook ADC Enrichment BD Difco Fluid Thioglycollate Medium with Beef Extract BD Difco CHROMagar Salmonella BD Difco MacConkey Sorbitol Agar BD Difco Urea Broth BD Difco Lactose BD Difco MacConkey Agar without Salt BD BBL Cary-Blair Transport Medium BD Difco Antimicrobic Vial K BD BBL Kligler Iron Agar BD Difco Decarboxylase Medium Base BD BBL Eosin Methylene Blue Agar, Levine BD Difco Pseudomonas Isolation Agar BD Difco Heart Infusion Agar BD Difco Yersinia Selective Agar Base BD BBL MacConkey Agar without Crystal Violet BD Difco Oxgall (Dehydrated Fresh Bile) BD Difco Cetrimide Agar Base BD Difco Dextrose BD Difco Soluble Starch BD BBL Fluid Thioglycollate Medium BD Difco Phenol Red Mannitol Agar BD BBL Moeller Decarboxylase Broth Base BD BBL Transport Medium BD BBL Urea Agar Base BD Difco Saccharose BD Difco Koser Citrate Medium BD Difco MIL Medium BD Difco Hektoen Enteric Agar BD Difco SS Agar BD Difco Beef Heart BD Difco OF Basal Medium BD ZeroFoam BD Horizon Brilliant Stain Buffer BD Detergent Solution Concentrate BD Extended Flow Cell Clean Solution BD Alcohol Blend Rinse BD MAX DNA MMK (SPC) BD FACSFlow Sheath Fluid BD BBL Schaedler Agar BD FACSRinse Solution BD Sheath Additive BD Disinfectant-nCL BD BBL Bovine Albumin (Fraction V) BD Difco Agar BD Difco Brain Heart Infusion Agar BD Stabilizing Fixative BD BBL Saline, Normal BD BBL Mannitol Salt Agar BD Difco Tryptic Soy Blood Agar Base No. 2 BD Difco Yeast Carbon Base BD Difco Cooked Meat Medium BD Difco MacConkey Broth BD Difco Candida BCG Agar Base BD Difco Pseudomonas Agar F BD BBL Phosphate Buffer, pH 7.2 BD BBL V-C-N Inhibitor BD BBL Mycosel Agar BD Difco MacConkey Agar Base BD FACS Sheath Solution with Surfactant BD Difco Lysine Iron Agar BD Difco Leptospira Medium Base EMJH BD BBL Phenol Red Broth Base BD Difco Potato Dextrose Broth BD BBL V-C-N-T Inhibitor BD Difco Sabouraud Brain Heart Infusion Agar Base BD BBL Brucella Broth BD Difco Veal Infusion Broth BD BBL Brucella Agar BD Difco Salicin BD Difco D-Sorbitol BD Difco Todd Hewitt Broth BD Difco Azide Blood Agar Base BD Difco Tinsdale Agar Base BD Difco Potato Dextrose Agar BD BBL Brain Heart Infusion BD Difco Columbia Blood Agar Base BD Difco SBG Sulfa Enrichment BD Difco Fraser Broth Supplement BD Difco Phenylalanine Agar BD Difco Brewer Anaerobic Agar BD Difco Columbia Broth BD BBL Inhibitory Mold Agar BD Difco Antimicrobic Vial A BD Difco Lysine Decarboxylase Broth BD BBL Trypticase Soy Broth BD BBL LBS Agar BD Difco Agar, Technical BD Difco Nutrient Broth BD BBL Seven H11 Agar Base BD Difco Nutrient Agar 1.5% BD BBL Columbia Agar Base BD BBL Dermatophyte Test Medium Base BD Difco D-Galactose BD Difco Nutrient Gelatin BD BBL Trypticase Soy Agar, Modified (TSA II) BD Difco Desoxycholate Agar BD BBL Brain Heart Infusion Broth, Modified BD Difco PPLO Agar BD BBL FTA Hemagglutination Buffer BD Difco Brilliant Green Agar BD Difco Middlebrook 7H9 Broth BD FACSClean Solution BD Difco Eugon Agar BD Difco MIO Medium BD Difco Tween 80 BD BBL Phenol Red Mannitol Broth BD Difco Novobiocin Antimicrobic Supplement BD Difco Asparagine BD BBL Select Agar BD Difco FA Buffer, Dried BD Difco Nutrient Agar BD BBL Enterococcosel Broth BD BBL Indole Nitrite Medium BD BBL Bile Esculin Agar BD BBL Blood Agar Base Infusion Agar BD Difco Agar, Noble BD BBL Corn Meal Agar BD BBL MR-VP Broth 659611_BD Horizon Brilliant Stain Buffer BD BBL Phenol Red Lactose Broth BD Difco Thioglycollate Medium without Indicator BD Difco ISP Medium 4 BD Difco Lowenstein Medium Base BD Difco Selenite Broth BD Difco Bile Salts No. 3 BD Difco Tryptic Soy Agar BD BBL MacConkey Agar BD BBL BiGGY Agar BD Difco Bordet Gengou Agar Base BD Difco Eugon Broth BD Difco Starch Agar BD BBL Trypticase Soy Broth, Sterile BD BBL TSN Agar BD Difco Tryptose Phosphate Broth BD BBL Simmons Citrate Agar BD BBL Motility Test Medium BD FACS Shutdown Solution BD Difco Sabouraud Dextrose Agar BD Difco Sabouraud Agar, Modified BD Difco Tryptose Broth BD Difco Cystine Tryptic Agar BD Difco Brain Heart Infusion BD Difco Gelatin BD BBL Vitamin K1 - Hemin Solution BD Difco D-Mannitol BD MAX DNA MMK BD BBL Egg Yolk Tellurite Enrichment BD Difco Mitis Salivarius Agar BD BBL MycoPrep Kit BD Difco PPLO Broth BD Difco Liver Infusion Broth BD Difco Glycerol BD Difco NIH Thioglycollate Broth BD BBL Phenylethyl Alcohol Agar BD Difco ISP Medium 2 BD Difco Fluid Thioglycollate Medium BD Difco DNase Test Agar BD Difco Tinsdale Enrichment Desiccated BD Difco Anaerobic Agar BD BBL Thioglycollate Medium, Brewer Modified BD MAX TNA MMK(SPC) BD Difco Sodium Desoxycholate BD BBL Trypticase Soy Agar BD Difco Purple Agar Base BD BBL Brain Heart Infusion Agar BD Difco Motility GI Medium BD Difco Tryptose Agar BD BBL GN Broth BD Difco GN Broth, Hajna BD BBL Mycophil Agar with Low pH BD Difco Columbia Agar Base II BD BBL Salmonella Shigella Agar BD Difco Purple Broth Base BD Difco Malonate Broth BD BBL Middlebrook OADC Enrichment BD Difco Leptospira Enrichment EMJH BD Difco Antimicrobic Vial P BD BBL Litmus Milk BD Difco GC Medium Base BD Difco EY Tellurite Enrichment BD Difco Triple Sugar Iron Agar BD Difco Pseudomonas Agar P BD BBL Phenol Red Dextrose Broth BD Difco Yersinia Antimicrobic Supplement CN BD Difco MacConkey Agar BD BBL IsoVitaleX Enrichment BD Difco Desoxycholate Lactose Agar BD Difco TCBS Agar BD Difco Brain Heart Infusion, Porcine BD BBL Mycoplasma Broth Base BD Rhamnose BD Difco Supplement B with Reconstituting Fluid BD Difco Dubos Broth Base BD BBL Agar, Grade A BD Difco Liver Veal Agar BD BBL Hemoglobin, Bovine, Freeze-Dried BD BBL Eosin Methylene Blue Agar, Modified BD BBL Columbia CNA Agar BD Difco Supplement VX with Reconstituting Fluid BD BBL CTA Medium BD BBL MacConkey II Agar BD BBL Mycoplasma Agar Base BD BBL BCYE Agar Base BD Difco Columbia Blood Agar Base EH BD BBL Spirolate Broth BD Difco XLD Agar BD Difco Sabouraud Dextrose Broth BD Difco Legionella Agar Enrichment BD Difco Heart Infusion Broth BD Difco Tryptic Soy Broth BD Difco Skim Milk BD Difco Maltose BD Difco Selenite Cystine Broth BD Difco Mycoplasma Supplement BD Difco Tryptose Blood Agar Base BD Difco Raffinose BD Difco Charcoal Agar BD Difco Agar, Granulated BD FACSCanto System Software BD FACSDiva Software BD CD3 (SK7) FITC (AKA Anti-Leu-4 FITC) BD FACSCount Control Kit BD FACSCount Reagent Kit BD FACSCount System Users Guide and Software BD FACSCount Instrument Anti-Cytokeratin BD FACSVia System BD CS&T Beads BD FACSVia clinical software BD Leucocount Kit FACSCanto Loader BD FACSCanto II w BD FACSCanto clinical sw & BD FACSDiva sw and BDFACSCanto w BDFACSCanto clinical sw and BD FACSDiva sw BD FACSPresto CD4/Hb Cartridge BD FACSPresto System BD FACSPresto CD4/Hb Cartridge Kit BD Tritest CD3/CD19/CD45 BD Trucount Tubes BD Tritest CD3/CD4/CD45 BD CD19(4G7) PE (AKA Anti-Leu-12 B Cell Reagent) BD Trucount Tubes BD Multitest 6 color TBNK with or without Trucount Tubes BD Simultest IMK Plus BD Simultest CD4/CD8 BD Simultest CD3/HLA-DR BD Simulset Software BD Simultest IMK-Lymphocyte BD Simultest CD3/CD4 BD Simultest CD3/CD19 BD Simultest CD3/CD8 BD Simultest CD3/CD16+56 BD Simultest IgG1/IgG2 BD Simultest Leucogate BD SimulSET Software BD Multitest 4-Color Assay Modules BD Multitest IMK Kit BD FACSLyric Flow Cytometer (4-2 optical configuration) BD CS&T Beads BD FACSLyric Flow Cytometer (4-3-3 optical configuration) BD Multitest CD3/CD8/CD45/CD4 BD FACSLyric Flow Cytometer (4-2-2 optical configuration) BD FACSuite Clinical Software BD FC Beads 7-Color Kit BD FACS Universal Loader BD FACSLyric Flow Cytometer (4-3-5 optical configuration) BD Multitest 6-Color Assay Modules BD FACSLyric Flow Cytometer (3-1 optical configuration) BD Trucount Tubes BD Multitest CD3/CD16+56/CD45/CD19 BD Simultest CD3/Anti-HLA-DR BD® Stem Cell Enumeration Kit BD® FACSuite Clinical Stem Cell Enumeration Assay Module BD Leucocount Reagent BD FACS 7-Color Setup Beads BD Leucocount Kit BD FACSuite Clinical BD Leucocount Assay Module BD FACSLyric Flow Cytometer BD Tritest Control g1/g1/CD45 BD Trucount Tubes BD Leucocount Combo Control BD Multi-Check CD4 Low Control BD Retic-Count Control BD Trucount Control Beads BD Multi-Check Control BD Leucocount RBC Control BD Leucocount PLT Control BD Trucount Tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2007-04-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-08-02
LIZ	Assay, T Lymphocyte Surface Marker	Hematology	Class 2	864.5220	2009-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-07
LYE	Cytokeratins	Immunology	Class 2	866.5550	2009-07-06
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2016-11-01
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2015-05-01
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2015-12-22
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2015-12-22
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2015-12-22
PMG	Automated Multicolor Fluorescent Imaging Cytometric Analysis System	Hematology	Class 2	864.5220	2015-12-22
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-01
LJD	Assay, B Lymphocyte Marker	Hematology	Class 2	864.5220	2009-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2010-07-06
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-06-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-06-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-10
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-10
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2017-07-17
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-10
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2022-04-26
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-01
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2023-08-24
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2018-01-04
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2009-07-06

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
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K781077	Dade, Baxter Travenol Diagnostics, Inc.	CONTROL, HEMATOLOGY, CH-60	1978-07-27

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-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008352382. Last updated year: 2026. Please use registration number 3008352382 when referencing this establishment in official correspondence.