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)
Sep 6, 2012Trek 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
MDBK032306
Mar 27, 2012Becton 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
MDBNone listed
Jul 28, 2011Becton 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
MDBK974883
Jun 23, 2011Becton 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
MDBNone listed
Jun 23, 2011Becton 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
MDBNone listed
May 24, 2011bioMerieux, 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
MDBK020813
Mar 8, 2010Becton 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
MDBK921133
Mar 8, 2010Becton 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
MDBK921133
Mar 8, 2010Becton 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
MDBK921133
Mar 8, 2010Becton 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
MDBK921133
Jan 4, 2008bioMerieux, Inc.
bioMerieux, BacT/ALERT FA Culture Bottles, bioMerieux, Inc., Durham, NC 27704
Terminated
MDBNone listed
May 18, 2007bioMerieux, Inc.
BacT/VIEW Software, all versions. in vitro diagnostic database software.
Terminated
MDBNone listed
May 3, 2007bioMerieux, Inc.
BacT/ALERT 3D 60 Systems Software, Blood Culturing System
Terminated
MDBK981736
May 3, 2007bioMerieux, Inc.
BacT/ALERT 3D Combo Systems Software, Blood Culturing System
Terminated
MDBK954468
May 3, 2007bioMerieux, Inc.
BacT/ALERT 3D System Software, Blood Culturing System
Terminated
MDBK934593
May 3, 2007bioMerieux, Inc.
BacT/ALERT Classic System Software, Blood Culturing System
Terminated
MDBK903505
Mar 22, 2007bioMerieux, 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
MDBK903505
K934593 +2
Mar 22, 2007bioMerieux, Inc.
BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
Terminated
MDBK020813
Dec 5, 2006bioMerieux, Inc.
bioMerieux BacT/ALERT SN Anaerobic Culture Bottle-REF 259790
Terminated
MDBK021123
Jun 22, 2006bioMerieux Inc
OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
Terminated
MDBNone listed
Sep 14, 2005Trek Diagnostic Systems
VersaTREK Myco AS.
Terminated
MDBNone listed
Sep 7, 2005BIOMERIEUX, INC.
Bac T/ALERT 3D 60
Terminated
MDBK903505
Sep 7, 2005BIOMERIEUX, INC.
Bac T/ALERT 3D Combination Module
Terminated
MDBK903505
Sep 7, 2005BIOMERIEUX, INC.
Bac T/ALERT 3D Control Module
Terminated
MDBK903505
Apr 13, 2005Trek 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
MDBNone listed
Feb 1, 2005bioMerieux
BacT/ALERT(BTA) Classic instruments.
Terminated
MDBK903505

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