Product Code: LRG


Products Classified as LRG

3444Instrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsAntimicrobial Susceptibility Test Powder.

Total Product Life Cycle (TPLC) Devices

3444Instrument For Auto Reader & Interpretation Of Overnight Suscept. SystemsAntimicrobial Susceptibility Test Powder.

FDA Consensus Standards

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems [33903]21 CFR §866.1640 🔎
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems [37758]21 CFR §866.1640 🔎
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems [37762]21 CFR §866.1640 🔎
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems [37761]21 CFR §866.1640 🔎
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems [37757]21 CFR §866.1640 🔎

Pre-market Notifications for LRG

K191918Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific
K191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific
K111677MICROSCAN(R) MICROSTREP PLUS(R)SIEMENS HEALTHCARE DIAGNOSTICS, INC.
K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELSSIEMENS HEALTHCARE DIAGNOSTICS, INC.
K110583SENSITITRE OPTIREADTREK DIAGNOSTIC SYSTEMS, LTD.
K103532AUTOREADER 2TREK DIAGNOSTIC SYSTEMS
K101425MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIESSIEMENS HEALTHCARE DIAGNOSTICS
K081013MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREENSIEMENS HEALTHCARE DIAGNOSTICS
K071316MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREENDADE BEHRING, INC.
K063299MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCINDADE BEHRING, INC.
K063102MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)DADE BEHRING, INC.
K063099MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)DADE BEHRING, INC.
K063101MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/MLDADE BEHRING, INC.
K063065MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)DADE BEHRING, INC.
K063064MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)DADE BEHRING, INC.

Global Unique Device Identification Database

15099590690892Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
15099590690885Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
15099590659646Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
15099590658687Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
15099590658663Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
15099590657987Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
M578V4000Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
00848838074530Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
05032384474530Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Maude Adverse Events

WALKAWAY96 PLUSBECKMAN COULTER2019-11-06
WA96 PLUS GENERICBECKMAN COULTER2019-08-08
WALKAWAY-40 SIBECKMAN COULTER2019-08-05
WALKAWAY-40 SIBECKMAN COULTER2017-03-14
LAB PRO MBTBECKMAN COULTER, INC.2016-08-22
WALK AWAY 40 PLUSBECKMAN COULTER2015-11-18
WALKAWAY 96 PLUSBECKMAN COULTER2015-08-25
WALKAWAY 40 PLUSBECKMAN COULTER2015-07-27
WALKAWAY 96 PLUSBECKMAN COULTER2015-07-23
BACT/ALERT BPN CULTURE BOTTLEBOIM?RIEUX, INC.2015-06-08
WALKAWAY 40 PLUSBECKMAN COULER2015-06-02
NEG BREAKPOINT COMBO 44BECKMAN COULTER2015-05-22
LABPRO COMPUTERBECKMAN COULTER2015-05-21
NEG URINE COMBO 62BECKMAN COULTER2015-05-20
NEG BREAKPOINT COMBO 47BECKMAN COULTER2015-05-20
NEG BREAKPOINT COMBO 41BECKMAN COULTER2015-05-20
NEG URINE COMBO 61BECKMAN COULTER2015-05-20
NEG URINE COMBO 62BECKMAN COULTER2015-05-20
NEG URIONE COMBO 61BECKMAN COULTER2015-05-20
NEG URINE COMBO 55BECKMAN COULTER2015-05-19
NEG ID2BECKMAN COULTER2015-05-19
NEG URINE COMBO 73BECKMAN COULTER2015-05-15
NEG BREAKPOINT COMBO 30BECKMAN COULTER2015-05-15
OVERNIGHT CONVENTIONAL GRAM NEGATIVE NUC66 PANELBECKMAN COULTER2015-05-15
NEG BREAKPOINT COMBO 30BECKMAN COULTER2015-05-15
NEG BREAKPOINT COMBO 30BECKMAN COULTER2015-05-15
NEG URINE COMBO 73BECKMAN COULTER2015-05-15
NEG URINE COMBO 73BECKMAN COULTER2015-05-15
NEG BREAKPOINT COMBO 47BECKMAN COULTER2015-05-15
OVERNIGHT CONVENTIONAL GRAM NEGATIVE NUC66 PANELBECKMAN COULTER2015-05-15
NEG URINE COMBO 51BECKMAN COULTER2015-05-13
WALKAWAY96BECKMAN COULTER2015-04-13
WALKAWAY96BECKMAN COULTER2015-03-02
WALKAWAY 40 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2015-01-30
WALKAWAY 96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2015-01-23
POSITIVE COMBO PANEL TYPE 33SIEMENS HEALTHCARE DIAGNOSTICS2014-12-30
POS COMBO 21SIEMENS HEALTHCARE DIAGNOSTICS, INC.2014-11-13
POS COMBO 21SIEMENS HEALTHCARE DIAGNOSTICS, INC.2014-11-13
MICROSCAN PANELSSIEMENS HEALTHCARE DIAGNOSTICS INC2014-10-10
LABPRO COMPUTERSIEMENS HEALTHCARE DIAGNOSTICS, INC.2014-09-25
POSITIVE COMBO 33SIEMENS HEALTHCARE DIAGNOSTICS INC2014-08-28
WA96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-08-27
WA96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-08-27
WALKAWAY 96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-06-27
WALKAWAY 40 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-06-27
WALKAWAY 96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-06-27
WALKAWAY 96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-06-27
WALKAWAY 96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-06-27
WALKAWAY 96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-06-27
WALKAWAY 96 PLUSSIEMENS HEALTHCARE DIAGNOSTICS2014-06-27
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