Product Code: LTT


Products Classified as LTT

3462Panels, Test, Susceptibility, AntimicrobialAntimicrobial Susceptibility Test Powder.

Total Product Life Cycle (TPLC) Devices

3462Panels, Test, Susceptibility, AntimicrobialAntimicrobial Susceptibility Test Powder.

FDA Consensus Standards

Panels, Test, Susceptibility, Antimicrobial [38133]21 CFR §866.1640 🔎
Panels, Test, Susceptibility, Antimicrobial [33903]21 CFR §866.1640 🔎
Panels, Test, Susceptibility, Antimicrobial [37758]21 CFR §866.1640 🔎
Panels, Test, Susceptibility, Antimicrobial [37762]21 CFR §866.1640 🔎
Panels, Test, Susceptibility, Antimicrobial [37761]21 CFR §866.1640 🔎
Panels, Test, Susceptibility, Antimicrobial [37757]21 CFR §866.1640 🔎

Pre-market Notifications for LTT

K193536MicroScan Dried Gram Negative MIC/Combo Panels With Ciprofloxacin (Cp) (0.004 - 8µg/mL)Beckman Coulter, Inc
K193358MicroScan Dried Gram-Negative MIC/Combo Panels With Levofloxacin (Lvx) (0.008-16ug/mL)Beckman Coulter, Inc.
K183127MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem/Vaborbactam (0.03/8-64/8ug/mL)Beckman Coulter, Inc.
K172912MicroScan Dried Gram-Negative MIC/Combo Panels With Ciprofloxacin-S (0.004 – 8 µg/mL)Beckman Coulter Inc.
K172337MicroScan Dried Gram Negative MIC/Combo Panels With Ceftazidime/Avibactam (0.25/4 - 64/4 Ug/mL)Beckman Coulter, Inc.
K172255MicroScan Dried Gram Negative MIC/Combo Panels With Ceftolozane/tazobactam (0.25/4 - 16/4 Ug/mL)Beckman Coulter, Inc
K162740MicroScan Dried Gram-Negative MIC/Combo Panels With Imipenem (0.25 - 8 Ug/mL)BECKMAN COULTER, INC.
K150039MicroScan Dried Gram Positive MIC/Combo Panels With Vancomycin (0.25-64 Mcg/mL)Siemens Healthcare Diagnostics Inc.
K131275MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELSSIEMENS HELATHCARE DIAGNOSTICS INC.
K123933MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINESIEMENS HEALTHCARE DIAGNOSTICS, INC.
K111394MICROSCAN MICROSTEPSiemens Healthcare Diagnostics Inc.
K091949MICROSCAN MICROSTREP PLUS, MODEL B1027-201SIEMENS HEALTHCARE DIAGNOSTICS
K091264MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017SIEMENS HEALTHCARE DIAGNOSTICS
K083262MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)SIEMENS HEALTHCARE DIAGNOSTICS
K062777MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCINDADE BEHRING, INC.

Global Unique Device Identification Database

15099590659608Panels, Test, Susceptibility, Antimicrobial
15099590657680Panels, Test, Susceptibility, Antimicrobial
03573026628123Panels, test, susceptibility, antimicrobial

Maude Adverse Events

POS COMBO 29 PANEL TYPEBECKMAN COULTER2017-02-22
POS COMBO 29 PANEL TYPEBECKMAN COULTER2017-02-07
POS COMBO 29 PANEL TYPEBECKMAN COULTER2017-02-07
POS COMBO PANEL TYPE 34BECKMAN COULTER INC2016-07-27
MICROSTREP PLUS1 PANELBECKMAN COULTER2015-09-15
NEG COMBO 50BECKMAN COULTER2015-05-13
NEG URINE COMBO 61BECKMAN COULTER2015-04-24
NEG URINE COMBO 33BECKMAN COULTER2015-04-24
NEG BREAKPOINT COMBO 34BECKMAN COULTER2015-04-24
NEG URINE COMBO 33BECKMAN COULTER2015-04-24
NEG BREAKPOINT COMBO 47BECKMAN COULTER2015-03-13
NEG BREAKPOINT COMBO 47BECKMAN COULTER2015-03-13
NEG URINE COMBO 73BECKMAN COULTER2015-03-13
NEG URINE COMBO 73BECKMAN COULTER2015-03-13
MICROSTREP PLUS TYPE 1 PANELSSIEMENS HEALTHCARE DIAGNOSTICS INC.2014-04-01
NEG BREAKPOINT COMBO 47SIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
NEG BREAKPOINT COMBO 47SIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
NEG BREAKPOINT COMBO 47SIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
NEG BREAKPOINT COMBO 47SIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
NEG BREAKPOINT COMBO 47SIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
MICROFAST 5JSIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
NEG BREAKPOINT COMBO 47SIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
MICROSTREP PLUS 1SIEMENS HEALTHCARE DIAGNOSTICS INC.2014-01-17
POSITIVE COMBO 33SIEMENS HEALTHCARE DIAGNOSTICS INC.2013-09-11
SYNERGIES PLUS NEGATIVE COMBO 3SIEMENS HEALTHCARE DIAGNOSTICS, INC.2013-09-11
SYNERGIES PLUS NEGATIVE URINE COMBO 2SIEMENS HEALTHCARE DIAGNOSTICS, INC.2013-09-11
SYNERGIES PLUS NEGATIVE URINE COMBO 2SIEMENS HEALTHCARE DIAGNOSTICS, INC.2013-09-11
GRAM NEGATIVE COMBO TYPE 44 PANELSIEMENS HEALTHCARE DIAGNOSTICS INC.2013-06-20
DRIED GRAM POSITIVE COMBO 33SIEMENS HEALTHCRE DIAGNOSTICS INC.2011-01-18
VITEK 2 AST GN24BIOMERIEUX2010-11-12
POS COMBO 6.1JSIEMENS HEALTHCARE DIAGNOSTICS INC.2009-08-13
DRIED POS MIC TYPE 20ASIEMENS HEALTHCARE DIAGNOSTICS INC.2008-02-20
DRIED POS MIC TYPE 20ASIEMENS HEALTHCARE DIAGNOSTICS INC2008-02-20
DRIED POS COMBO TYPE 20SIEMENS HEALTHCARE DIAGNOSTICS INC.,2008-01-10
DRIED POS COMBO TYPE 20SIEMENS HEALTHCARE DIAGNOSTICS INC.,2008-01-10
DRIED POS MIC TYPE 23DADE BEHRING, INC.2007-08-28
DRIED POS COMBO TYPE 21DADE BEHRING, INC.2007-07-12
BACT/ALERT - BPA BOTTLEBIOMERIEUX, INC.2007-05-25
DRIED POS COMBO TYPE 26DADE BEHRING, INC.2007-05-18
DRIED POS COMBO TYPE 21DADE BEHRING, INC.2007-04-18
DRIED POS COMBO TYPE 20DADE BEHRING, INC.2007-04-17
VITEK 2 SYSTEMBIOMERIEUX, INC.2007-02-01
DRIED POS COMBO TYPE 21DADE BEHRING, INC.2006-11-15
DRIED POS COMBO TYPE 20DADE BEHRING, INC.2006-11-10
DRIED POS MIC PANEL TYPE 23DADE BEHRING INC.2006-10-04
DRIED POS MIC PANEL TYPE 20ADADE BEHRING, INC.2006-10-04
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CMBIOENTERICS CORPORATION2006-09-25
DRIED POS MIC PANEL TYPE 20ADADE BEHRING, INC.2006-08-30
DRIED POS MIC PANEL TYPE 20ADADE BEHRING, INC.2006-07-24
DRIED POS MIC PANEL TYPE 20ADADE BEHRING, INC.2006-07-24
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