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MDB — System, Blood Culturing Class I

FDA Device Classification

Classification Details

Product Code
MDB
Device Class
Class I
Regulation Number
866.2560
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222591becton, dickinson andBD BACTEC™ Plus Aerobic/F Culture VialsMarch 24, 2023
K222559becton, dickinson andBD BACTEC™ Myco/F Lytic Culture VialsMarch 24, 2023
K190405biomerieuxBACT/ALERT MP Reagent SystemMay 15, 2019
K183166biomerieuxBacT/ALERT FA Plus; BacT/ALERT PF PlusFebruary 11, 2019
K173873becton, dickinson andBD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in aMarch 16, 2018
K161816biomerieuxBacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUOMarch 28, 2017
K161810becton dickinsonBD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a PFebruary 9, 2017
K161306becton dickinsonBD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a PlAugust 8, 2016
K151866becton, dickinson andBD BACTEC Peds Plus/F Culture Vials (plastic)February 25, 2016
K141810becton, dickinson andBD BACTEC PLUS ANAEROBIC/F (PLASTIC)December 10, 2014
K123903becton, dickinson andBACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)May 13, 2013
K121446biomerieuxBACT/ALERT PF PLUS CULTURE BOTTLEJanuary 25, 2013
K121455biomerieuxBACT/ALERT FN PLUS CULTURE BOTTLEJanuary 25, 2013
K121461biomerieuxBACT/ALERT FA PLUS CULTURE BOTTLEJanuary 22, 2013
K120994becton, dickinson andBD BACTEC Plus PRIME Aerobic/F Culture VialsAugust 7, 2012
K113558becton, dickinson andBD BACTEC Plus Aerobic/F Culture Vials (plastic)March 16, 2012
K083572becton, dickinson andBD BACTEC Plus Aerobic/F Culture VialsDecember 24, 2008
K032306trek diagnostic systemsVERSATREKAugust 22, 2003
K031737biomerieuxBACT/ALERT MP CULTURE BOTTLES (PLASTIC)July 14, 2003
K021123biomerieuxBACT/ALERT SN CULTURE BOTTLEApril 26, 2002