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) |
|---|---|---|---|
| Sep 6, 2012 | Trek Diagnostic Systems VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer
T Terminated |
MDB | K032306 |
| Mar 27, 2012 | Becton Dickinson & Co. BD BBL (tm) Lowenstein-Jensen Medium Deeps, Catalog #221256, packaged in boxes of ten/600 mL tubes. Product Usage: Lowenstein-Jensen Medium is used for the isolation and cultivation of mycobacteria. Terminated |
MDB | None listed |
| Jul 28, 2011 | Becton Dickinson & Co. BD BACTEC(tm) MGI (tm) System Software, Catalog 445922, Lot V5.02A.
Product Usage: The BACTEC(tm) MGIT (tm) System Software is used in the MGIT 960 and MGIT 320 instruments for the rapid detection Terminated |
MDB | K974883 |
| Jun 23, 2011 | Becton Dickinson & Co. BACTEC" FX Instrument-Top, catalog #441385.
The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injecte Terminated |
MDB | None listed |
| Jun 23, 2011 | Becton Dickinson & Co. BACTEC" FX System Software, catalog #441398 and #441750
The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients a Terminated |
MDB | None listed |
| May 24, 2011 | bioMerieux, Inc. BacT/ALERT - FA Reagent Bottle
The BacT/ALERT Microbial Detection System is used to determine if microorganisms are present in blood or other normally sterile body fluid samples taken from a patient s Terminated |
MDB | K020813 |
| Mar 8, 2010 | Becton Dickinson & Co. BD BACTEC(TM) Plus Anaerobic/F Medium, catalog 442193, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152***
BD BACTEC Media are used in a qualitativ Terminated |
MDB | K921133 |
| Mar 8, 2010 | Becton Dickinson & Co. BD BACTEC(TM) Standard 10 Aerobic/F Medium, catalog 442260, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152***
BD BACTEC Media are used in a quali Terminated |
MDB | K921133 |
| Mar 8, 2010 | Becton Dickinson & Co. BD BACTEC(TM) Lytic 10 Anaerobic/F Medium, catalog 442265, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152***
BD BACTEC Media are used in a quali Terminated |
MDB | K921133 |
| Mar 8, 2010 | Becton Dickinson & Co. BD BACTEC(TM) Plus + Aerobic/F Medium, catalog 442192, packed in tubes, 50 tubes/case and labeled in part ***Becton Dickinson and Company, Sparks, MD 21152***
BD BACTEC Media are used in a qualitativ Terminated |
MDB | K921133 |
| Jan 4, 2008 | bioMerieux, Inc. bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704 Terminated |
MDB | None listed |
| May 18, 2007 | bioMerieux, Inc. BacT/VIEW Software, all versions. in vitro diagnostic database software. Terminated |
MDB | None listed |
| May 3, 2007 | bioMerieux, Inc. BacT/ALERT 3D 60 Systems Software, Blood Culturing System Terminated |
MDB | K981736 |
| May 3, 2007 | bioMerieux, Inc. BacT/ALERT 3D Combo Systems Software, Blood Culturing System Terminated |
MDB | K954468 |
| May 3, 2007 | bioMerieux, Inc. BacT/ALERT 3D System Software, Blood Culturing System Terminated |
MDB | K934593 |
| May 3, 2007 | bioMerieux, Inc. BacT/ALERT Classic System Software, Blood Culturing System Terminated |
MDB | K903505 |
| Mar 22, 2007 | bioMerieux, Inc. BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA Terminated |
MDB | K903505 K934593 +2 |
| Mar 22, 2007 | bioMerieux, Inc. BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704 Terminated |
MDB | K020813 |
| Dec 5, 2006 | bioMerieux, Inc. bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790 Terminated |
MDB | K021123 |
| Jun 22, 2006 | bioMerieux Inc OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D Terminated |
MDB | None listed |
| Sep 14, 2005 | Trek Diagnostic Systems VersaTREK Myco AS. Terminated |
MDB | None listed |
| Sep 7, 2005 | BIOMERIEUX, INC. Bac T/ALERT 3D 60 Terminated |
MDB | K903505 |
| Sep 7, 2005 | BIOMERIEUX, INC. Bac T/ALERT 3D Combination Module Terminated |
MDB | K903505 |
| Sep 7, 2005 | BIOMERIEUX, INC. Bac T/ALERT 3D Control Module Terminated |
MDB | K903505 |
| Apr 13, 2005 | Trek Diagnostic Systems Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. Terminated |
MDB | None listed |
| Feb 1, 2005 | bioMerieux BacT/ALERT(BTA) Classic instruments. Terminated |
MDB | K903505 |
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