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)
Top companies in MDB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2025 | Becton 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 |
MDB | K922475 |
| Oct 23, 2025 | Becton 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 |
MDB | K915796 |
| Dec 3, 2024 | Becton Dickinson & Co. BACTEC 9240 System
Version or Model: 445475
Catalog Number: 445475 Open, Classified |
MDB | K915796 |
| Dec 3, 2024 | Becton Dickinson & Co. BACTEC 9120 System
Version or Model: 445570
Catalog Number: 445570 Open, Classified |
MDB | K922475 |
| Dec 3, 2024 | Becton Dickinson & Co. BD BACTEC FX40 Instrument
Version or Model: 442296
Catalog Number: 442296 Open, Classified |
MDB | K915796 |
| Dec 3, 2024 | Becton Dickinson & Co. BD BACTEC FX, Instrument Top, Packaged
Version or Model: 441385
Catalog Number: 441385 Open, Classified |
MDB | K915796 |
| Oct 12, 2023 | Becton Dickinson & Co. BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 Open, Classified |
MDB | K113558 |
| Jun 27, 2018 | bioMerieux, 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 |
MDB | None listed |
| Jun 27, 2018 | bioMerieux, 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 |
MDB | None listed |
| Jun 27, 2018 | bioMerieux, 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 |
MDB | None listed |
| Dec 24, 2015 | bioMerieux, 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 |
MDB | K020813 |
| Dec 24, 2015 | bioMerieux, 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 |
MDB | K993421 |
| Jun 25, 2015 | Remel 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 |
MDB | None listed |
| Jun 25, 2015 | Remel 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 |
MDB | None listed |
| Jul 15, 2014 | Remel 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 |
MDB | K032306 |
| Jan 30, 2014 | Becton 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 |
MDB | K915796 |
| Jan 30, 2014 | Becton 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 |
MDB | K915796 |
| Oct 19, 2013 | Becton 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 |
MDB | K974883 |
| Jan 25, 2013 | bioMerieux, 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 |
MDB | K020931 |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
| Nov 16, 2012 | Biomerieux 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 |
MDB | None listed |
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