Product code MDB— Microbiology
BACTEC MYCO/F LYTIC CULTURE VIALS
- Classification name
- System, Blood Culturing
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Total cleared
- 68
- First cleared
- Most recent
Market context for product code MDB
FDA has cleared devices under product code MDB between 1981 and 2026, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
last 15 years- 2026
- 2023
- 2019
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2008
- 2003
- 2002
- 2000
- 1999
- 1998
Top applicants under product code MDB
Adverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MDB
- K260213 — BD BACTEC FXI Culture System
- K222559 — BD BACTEC Myco/F Lytic Culture Vials
- K222591 — BD BACTEC Plus Aerobic/F Culture Vials
- K190405 — BACT/ALERT MP Reagent System
- K183166 — BacT/ALERT FA Plus; BacT/ALERT PF Plus
- K173873 — BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
- K161816 — BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
- K161810 — BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
- K161306 — BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial
- K151866 — BD BACTEC Peds Plus/F Culture Vials (plastic)
- K141810 — BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
- K123903 — BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
- K121446 — BACT/ALERT PF PLUS CULTURE BOTTLE
- K121455 — BACT/ALERT FN PLUS CULTURE BOTTLE
- K121461 — BACT/ALERT FA PLUS CULTURE BOTTLE
- K120994 — BD BACTEC Plus PRIME Aerobic/F Culture Vials
- K113558 — BD BACTEC Plus Aerobic/F Culture Vials (plastic)
- K083572 — BD BACTEC Plus Aerobic/F Culture Vials
- K032306 — VERSATREK
- K031737 — BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
- K021123 — BACT/ALERT SN CULTURE BOTTLE
- K020815 — BACT/ALERT FN CULTURE BOTTLE
- K020923 — BACT/ALERT PF CULTURE BOTTLE
- K020931 — BACT/ALERT SA CULTURE BOTTLE
- K020813 — BACT/ALERT FA CULTURE BOTTLE
- K000378 — BACT/ALERT MB CULTURE BOTTLE
- K994343 — BACT/ALERT SV
- K993423 — BACT/ALERT SA
- K993421 — BACT/ALERT SN
- K993576 — BACT/ALERT MP PROCESS BOTTLE
- K992432 — BACT/ALERT FN
- K992400 — BACTALERT FA
- K992401 — BACT/ALERT PF
- K983772 — MB/BACT BLOOD CULTURE BOTTLE
- K982263 — MB/BACT BLOOD CULTURE BOTTLE
- K981736 — BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
- K974883 — BACTEC MGIT 960 SYSTEM
- K970333 — BACTEC MYCO/F LYTIC CULTURE VIALS
- K970512 — BACTEC MYCO/F LYTIC CULTURE VIALS
- K973325 — BACT/ALERT FAN CULTURE BOTTLES
- K973305 — BACT/ALERT CULTURE BOTTLES
- K972758 — BACTEC MYCO/F-SPUTA CULTURE VIALS
- K972756 — MODIFICATION OF EST CULTURE SYSTEM II - MYCO
- K954932 — BBL MGIT PRODUCTS
- K962210 — BACTEC 9050 SYSTEM
- K954468 — MB/BACT MYCROBACTERIA DETECTION SYSTEM
- K946268 — BACTEC(R) 9000TB SYSTEM
- K954921 — BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
- K954925 — BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
- K954927 — BACTEC PEDS PLUS/F CULTURE VIALS
- K954930 — BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
- K954924 — BACTEC PEDS PLUS CLUTURE VIALS
- K953129 — ESP CULTURE SYSTEM - MYCO
- K944594 — BACT/ALERT FAN CULTURE BOTTLE
- K935711 — BACT/ALERT FAN AEROBIC CULTURE BOTTLE
- K934593 — BACT/ALERT 120
- K926304 — BACTEC PEDS PLUS/F
- K925693 — EZ VIEW
- K921637 — ESP BLOOD CULTURE SYSTEM
- K922475 — BACTEC 9120 SYSTEM
- K920249 — BACT/ALERT PEDI-BACT
- K915796 — BACTEC 9240 SYSTEM
- K921133 — BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
- K920933 — BACTEC FOS CULTURE SUPPLEMENT
- K903505 — BACT/ALERT (TM)
- K833888 — PENASE
- K812315 — BACTEC RESIN CULTURE MED. 16A
- K810613 — ANTIMICROBIAL REMOVAL DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.