Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Blood Culturing

FDA product code MDB · 67 cleared devices

Class 1 Microbiology

Regulation: 21 CFR 866.2560
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-04-03 – 2026-05-28

MDB 2026-05-28

BD BACTEC FXI Culture System

Applicant BD Diagnostic Systems

K number K260213

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MDB 2023-03-24

BD BACTEC™ Plus Aerobic/F Culture Vials

Applicant Becton, Dickinson and Company

K number K222591

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MDB 2023-03-24

BD BACTEC™ Myco/F Lytic Culture Vials

Applicant Becton, Dickinson and Company

K number K222559

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MDB 2019-05-15

BACT/ALERT MP Reagent System

Applicant bioMerieux, Inc.

K number K190405

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MDB 2019-02-11

BacT/ALERT FA Plus; BacT/ALERT PF Plus

Applicant bioMerieux, Inc.

K number K183166

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MDB 2018-03-16

BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial

Applicant Becton, Dickinson and Company

K number K173873

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MDB 2017-03-28

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

Applicant bioMerieux, Inc.

K number K161816

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MDB 2017-02-09

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Applicant Becton Dickinson

K number K161810

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MDB 2016-08-08

BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Applicant Becton Dickinson

K number K161306

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MDB 2016-02-25

BD BACTEC Peds Plus/F Culture Vials (plastic)

Applicant Becton, Dickinson and Company

K number K151866

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MDB 2013-05-13

BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)

Applicant Becton, Dickinson & CO

K number K123903

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MDB 2013-01-25

BACT/ALERT FN PLUS CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K121455

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MDB 2013-01-25

BACT/ALERT PF PLUS CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K121446

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MDB 2013-01-22

BACT/ALERT FA PLUS CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K121461

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MDB 2012-08-07

BD BACTEC Plus PRIME Aerobic/F Culture Vials

Applicant Becton, Dickinson and Company

K number K120994

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MDB 2012-03-16

BD BACTEC Plus Aerobic/F Culture Vials (plastic)

Applicant Becton, Dickinson and Company

K number K113558

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MDB 2008-12-24

BD BACTEC Plus Aerobic/F Culture Vials

Applicant Becton, Dickinson & CO

K number K083572

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MDB 2003-08-22

VERSATREK

Applicant Trek Diagnostic Systems, Inc.

K number K032306

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MDB 2003-07-14

BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

Applicant bioMerieux, Inc.

K number K031737

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MDB 2002-04-26

BACT/ALERT SN CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K021123

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MDB 2002-04-18

BACT/ALERT SA CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K020931

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MDB 2002-04-18

BACT/ALERT PF CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K020923

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MDB 2002-04-18

BACT/ALERT FN CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K020815

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MDB 2002-04-17

BACT/ALERT FA CULTURE BOTTLE

Applicant bioMerieux, Inc.

K number K020813

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MDB 2000-03-02

BACT/ALERT MB CULTURE BOTTLE

Applicant Organon Teknika Corp.

K number K000378

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MDB 2000-02-10

BACT/ALERT SV

Applicant Organon Teknika Corp.

K number K994343

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MDB 1999-12-15

BACT/ALERT SA

Applicant Organon Teknika Corp.

K number K993423

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MDB 1999-12-14

BACT/ALERT MP PROCESS BOTTLE

Applicant Organon Teknika Corp.

K number K993576

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MDB 1999-12-14

BACT/ALERT SN

Applicant Organon Teknika Corp.

K number K993421

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MDB 1999-09-24

BACT/ALERT FN

Applicant Organon Teknika Corp.

K number K992432

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MDB 1999-09-03

BACT/ALERT PF

Applicant Organon Teknika Corp.

K number K992401

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MDB 1999-09-03

BACTALERT FA

Applicant Organon Teknika Corp.

K number K992400

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MDB 1999-01-13

MB/BACT BLOOD CULTURE BOTTLE

Applicant Organon Teknika Corp.

K number K983772

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MDB 1998-08-18

MB/BACT BLOOD CULTURE BOTTLE

Applicant Organon Teknika Corp.

K number K982263

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MDB 1998-07-24

BACT/ALERT 3D MICROBIAL DETECTION SYSTEM

Applicant Organon Teknika Corp.

K number K981736

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MDB 1998-05-01

BACTEC MGIT 960 SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K974883

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MDB 1998-01-28

BACTEC MYCO/F LYTIC CULTURE VIALS

Applicant Becton Dickinson Microbiology Systems

K number K970333

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MDB 1998-01-08

BACTEC MYCO/F LYTIC CULTURE VIALS

Applicant Becton Dickinson Microbiology Systems

K number K970512

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MDB 1997-12-02

BACT/ALERT FAN CULTURE BOTTLES

Applicant Organon Teknika Corp.

K number K973325

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MDB 1997-11-17

BACT/ALERT CULTURE BOTTLES

Applicant Organon Teknika Corp.

K number K973305

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MDB 1997-08-08

BACTEC MYCO/F-SPUTA CULTURE VIALS

Applicant Becton Dickinson Microbiology Systems

K number K972758

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MDB 1997-08-01

MODIFICATION OF EST CULTURE SYSTEM II - MYCO

Applicant Accumed Intl., Inc.

K number K972756

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MDB 1996-08-21

BBL MGIT PRODUCTS

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K954932

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MDB 1996-08-08

BACTEC 9050 SYSTEM

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K962210

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MDB 1996-07-22

MB/BACT MYCROBACTERIA DETECTION SYSTEM

Applicant Organon Teknika Corp.

K number K954468

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MDB 1996-05-21

BACTEC(R) 9000TB SYSTEM

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K946268

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MDB 1996-02-16

BACTEC CULTURE VIALS, LYTIC, ANAEROBIC

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K954930

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MDB 1996-02-16

BACTEC PEDS PLUS/F CULTURE VIALS

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K954927

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MDB 1996-02-16

BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K954925

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MDB 1996-02-16

BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K954921

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MDB 1996-02-08

BACTEC PEDS PLUS CLUTURE VIALS

Applicant Becton Dickinson Diagnostic Instrument Systems

K number K954924

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MDB 1995-12-26

ESP CULTURE SYSTEM - MYCO

Applicant Difco Laboratories, Inc.

K number K953129

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MDB 1995-02-17

BACT/ALERT FAN CULTURE BOTTLE

Applicant Organon Teknika Corp.

K number K944594

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MDB 1994-08-30

BACT/ALERT FAN AEROBIC CULTURE BOTTLE

Applicant Organon Teknika Corp.

K number K935711

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MDB 1994-02-09

BACT/ALERT 120

Applicant Organon Teknika Corp.

K number K934593

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MDB 1993-03-04

BACTEC PEDS PLUS/F

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K926304

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MDB 1993-01-15

EZ VIEW

Applicant Difco Laboratories, Inc.

K number K925693

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MDB 1992-07-14

ESP BLOOD CULTURE SYSTEM

Applicant Difco Laboratories, Inc.

K number K921637

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MDB 1992-07-01

BACTEC 9120 SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K922475

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MDB 1992-04-23

BACT/ALERT PEDI-BACT

Applicant Organon Teknika Corp.

K number K920249

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MDB 1992-04-22

BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K921133

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MDB 1992-04-22

BACTEC 9240 SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K915796

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MDB 1992-04-17

BACTEC FOS CULTURE SUPPLEMENT

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K920933

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MDB 1991-03-12

BACT/ALERT (TM)

Applicant Organon Teknika Corp.

K number K903505

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MDB 1984-01-03

PENASE

Applicant Oxoid U.S.A., Inc.

K number K833888

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MDB 1981-11-10

BACTEC RESIN CULTURE MED. 16A

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K812315

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MDB 1981-04-03

ANTIMICROBIAL REMOVAL DEVICE

Applicant Marion Laboratories, Inc.

K number K810613

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