System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Product Code: PEX

Microbiology Medical Laser Products

Definition: A Mass Spectrometer System Using Matrix-assisted Laser Desorption/ Ionization - Time Of Flight (maldi-tof) For The Identification Of Microorganisms Cultured From Human Specimens.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 866.3361


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as PEX

3561System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMass Spectrometer System For Clinical Use For The Identification Of Microorganisms.

Total Product Life Cycle (TPLC) Devices

3561System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMass Spectrometer System For Clinical Use For The Identification Of Microorganisms.

Pre-market Notifications for PEX

K193419MBT SepsityperBruker Daltonik GmbH
K163536MALDI Biotyper CA (MBT-CA) System, MBT Smart CA SystemBRUKER DALTONIK GMBH
K162950VITEK MSBioMerieux, Inc.
K142677MALDI Biotyper CA SystemBRUKER DALTONICS, INC
K130831MALDI BIOTYPER CA (MBT-CA) SYSTEMBRUKER DALTONICS, INC

Global Unique Device Identification Database

04251204325789System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204325772System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204325734System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204325710System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204325666System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204325659System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204325642System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204300014System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
03573026610418System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
04251204326168System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
10841594110099System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
10841594110013System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
10841594110020System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
00841594110047System, mass spectrometry, maldi tof, microorganism identification, cultured isolates
00841594110030System, mass spectrometry, maldi tof, microorganism identification, cultured isolates

Maude Adverse Events

VITEK? MS INSTRUMENTBIOM?RIEUX, SA2020-03-26
VITEK? MS INSTRUMENTBIOMERIEUX, SA2020-03-26
VITEK? MSBIOMERIEUX, SA2020-03-25
VITEK? MS RP5700 ACQU COMP KITBIOMERIEUX, SA2020-03-25
VITEK MS INSTRUMENTBIOMERIEUX, SA2020-03-24
VITEK? MS INSTRUMENTBIOMERIEUX, SA2020-03-24
VITEK MS INSTRUMENT - 410895BIOM?RIEUX, SA2020-03-19
VITEK MS INSTRUMENT - 410895BIOM?RIEUX, SA2020-03-18
VITEK? MS INSTRUMENTBIOMERIEUX, SA2020-03-13
VITEK? MS INSTRUMENTBIOMERIEUX, SA2020-03-11
VITEK? MSBIOMERIEUX, SA2020-02-28
VITEK MS INSTRUMENT - 410895BIOM?RIEUX, SA2020-02-26
VITEK? MSBIOMERIEUX, SA2020-02-26
VITEK? MS - 412550BIOMERIEUX, SA2020-02-20
VITEK? MSBIOMERIEUX, SA2020-02-20
VITEK? MSBIOMERIEUX, SA2020-02-20
VITEK? MSBIOMERIEUX, SA2020-02-14
VITEK? MSBIOMERIEUX, SA2020-02-14
VITEK? MSBIOMERIEUX, SA2020-02-07
VITEK? MSBIOMERIEUX, SA2020-01-29
VITEK? MSBIOMERIEUX, SA2020-01-27
VITEK? MS INSTRUMENT - 410895BIOMERIEUX, SA2020-01-13
VITEK? MSBIOMERIEUX, SA2020-01-10
VITEK? MSBIOMERIEUX, SA2020-01-09
VITEK? MSBIOMERIEUX, SA2020-01-09
VITEK? MSBIOMERIEUX, SA2020-01-09
VITEK? MSBIOMERIEUX, SA2020-01-09
VITEK? MSBIOMERIEUX, SA2020-01-09
VITEK? MSBIOMERIEUX, SA2020-01-03
VITEK? MSBIOMERIEUX, SA2020-01-02
VITEK? MSBIOMERIEUX, SA2019-12-27
VITEK? MSBIOMERIEUX, SA2019-12-18
VITEK? MSBIOMERIEUX, SA2019-12-17
VITEK? MS INSTRUMENT - 410895BIOMERIEUX, SA2019-12-13
VITEK? MSBIOMERIEUX, SA2019-12-12
VITEK? MSBIOMERIEUX, SA2019-11-27
VITEK? MSBIOMERIEUX, SA2019-11-22
VITEK? MSBIOMERIEUX, SA2019-11-22
VITEK? MSBIOMERIEUX, SA2019-11-22
VITEK? MSBIOMERIEUX, SA2019-11-13
VITEK? MSBIOMERIEUX, SA2019-11-13
VITEK? MSBIOMERIEUX, SA2019-11-13
VITEK? MSBIOMERIEUX, SA2019-11-12
VITEK? MSBIOMERIEUX, SA2019-11-12
VITEK? MSBIOMERIEUX, SA2019-11-12
VITEK? MSBIOMERIEUX, SA2019-11-07
VITEK? MSBIOMERIEUX, SA2019-10-29
VITEK? MSBIOMERIEUX, SA2019-10-23
VITEK? MSBIOMERIEUX, SA2019-10-15
VITEK? MS MYCOBACTERIUM/NOCARDIA KITBIOMERIEUX, SA2019-10-14
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