ClearanceBrief
Panels › Microbiology › Product code MDB · Class 1

System, Blood Culturing

Regulation 866.2560

1510(k)s in 12 months (68 all time)
0recalls in 12 months (76 all time)
32recalls that name a 510(k)
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Top companies in MDB

DateFirm and productCodeLinked 510(k)
Oct 23, 2025Becton Dickinson & Co.
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.
Open, Classified
MDBK922475
Oct 23, 2025Becton Dickinson & Co.
BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3
Open, Classified
MDBK915796
Dec 3, 2024Becton Dickinson & Co.
BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
Open, Classified
MDBK915796
Dec 3, 2024Becton Dickinson & Co.
BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
Open, Classified
MDBK922475
Dec 3, 2024Becton Dickinson & Co.
BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
Open, Classified
MDBK915796
Dec 3, 2024Becton Dickinson & Co.
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
Open, Classified
MDBK915796
Oct 12, 2023Becton Dickinson & Co.
BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023
Open, Classified
MDBK113558
Jun 27, 2018bioMerieux, Inc.
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitatin
Terminated
MDBNone listed
Jun 27, 2018bioMerieux, Inc.
BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and
Terminated
MDBNone listed
Jun 27, 2018bioMerieux, Inc.
BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and
Terminated
MDBNone listed
Dec 24, 2015bioMerieux, Inc.
BacT/ALERT FA, bioMrieux, Inc., Product Usage: BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aero
Terminated
MDBK020813
Dec 24, 2015bioMerieux, Inc.
BacT/ALERT SN, bioMrieux, Inc. Product Usage: BacT/ALERT Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerob
Terminated
MDBK993421
Jun 25, 2015Remel Inc
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other nor
Terminated
MDBNone listed
Jun 25, 2015Remel Inc
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other norm
Terminated
MDBNone listed
Jul 15, 2014Remel Inc
Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
Terminated
MDBK032306
Jan 30, 2014Becton Dickinson & Co.
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi
Terminated
MDBK915796
Jan 30, 2014Becton Dickinson & Co.
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton C
Terminated
MDBK915796
Oct 19, 2013Becton Dickinson & Co.
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
Terminated
MDBK974883
Jan 25, 2013bioMerieux, Inc.
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids
Terminated
MDBK020931
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 413484 Software update for an instrument which is most commonl
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 Software update for an instrument which is most commonl
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software update for an instrument which is most commonly used to i
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonl
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software update for an instrument which is most commonly used to
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 Software update for an instrument which is most commo
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update, English, Spanish, Italian, German, French, Japanese, Brazilian, Portuguese, catalog number 412950 Software upd
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software update, English, Spanish, Italian, catalog number 412006 Software update for an instrument which is most commonly u
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Software update for an instrument which is most commonly u
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients tha
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412622 Software update for the clinica
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412621 Software update for the clinical instrument which is m
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 Software update for the clinical instrument which is m
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 Software update for the clinical instrument which is
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Software update for the clinical instrument which is most
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957 Software update for the clinical instrument which is most co
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Software update for the clinical instrument which is most common
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software update for the clinical instrument which is most commonly
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Software update for the clinical instrument which is most common
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, catalog number 412626 Software update for the clinic
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 412625 Software update for the clinical instrument which is
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412624 Software update for the clinical instrument which is
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Software update for the clinical instrument which is mos
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the clinical instrument which is most commonly used to isola
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software, English, Spanish, Italian, catalog number 411815 Software update for the clinical instrument which is most commo
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411814 Software update for the clinical instrument which is most common
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acut
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that a
Terminated
MDBNone listed
Nov 16, 2012Biomerieux Inc
bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that
Terminated
MDBNone listed

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