Product Code: LTW


Products Classified as LTW

3463Susceptibility Test Cards, AntimicrobialAntimicrobial Susceptibility Test Powder.

Total Product Life Cycle (TPLC) Devices

3463Susceptibility Test Cards, AntimicrobialAntimicrobial Susceptibility Test Powder.

FDA Consensus Standards

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

Pre-market Approvals for LTW

N50510VITEK 2 GRAM POSITIVE AST FOR VANCOMYCINBIOMERIEUX VITEK, INC.

Pre-market Notifications for LTW

K853596PRECEPT CEFOPERAZONEAUSTIN BIOLOGICAL LABORATORIES
K853263PRECEPT AVGMENTINAUSTIN BIOLOGICAL LABORATORIES
K853273PRECEPT CEFTRIAXONEAUSTIN BIOLOGICAL LABORATORIES
K853053PRECEPT ERYTHROMYCINAUSTIN BIOLOGICAL LABORATORIES
K852613MIC-CONCEPT SYSTEMMICROTECH MEDICAL SYSTEMS, INC.
K853772PRECEPT METHICILLINAUSTIN BIOLOGICAL LABORATORIES
K853685PRECEPT TM CARBENICILLINAUSTIN BIOLOGICAL LABORATORIES
K853684PRECEPT KANAMYCINAUSTIN BIOLOGICAL LABORATORIES
K853686PRECEPT TM AMIKACINAUSTIN BIOLOGICAL LABORATORIES
K853687PRECEPT NETILMICIN 32-13AUSTIN BIOLOGICAL LABORATORIES
K853689PRECEPT TM MOXALACTAMAUSTIN BIOLOGICAL LABORATORIES
K853688PRECEPT TM TOBRAMYCINAUSTIN BIOLOGICAL LABORATORIES
K850347API UNISCEPT KBANALYTICAL PRODUCTS, INC.
K844159API UNISCEPT MIC 100ULANALYTICAL PRODUCTS, INC.
K843733API UNISCEPT KBANALYTICAL PRODUCTS, INC.

Global Unique Device Identification Database

15099590704063Susceptibility Test Cards, Antimicrobial
15099590704056Susceptibility Test Cards, Antimicrobial
15099590704025Susceptibility Test Cards, Antimicrobial
15099590658038Susceptibility Test Cards, Antimicrobial
15099590658021Susceptibility Test Cards, Antimicrobial
15099590658007Susceptibility Test Cards, Antimicrobial
15099590657994Susceptibility Test Cards, Antimicrobial
15099590657956Susceptibility Test Cards, Antimicrobial
15099590657949Susceptibility Test Cards, Antimicrobial
15099590657895Susceptibility Test Cards, Antimicrobial
15099590657550Susceptibility Test Cards, Antimicrobial
15099590657536Susceptibility Test Cards, Antimicrobial
15099590657512Susceptibility Test Cards, Antimicrobial
03573026617943Susceptibility test cards, antimicrobial

Maude Adverse Events

VITEK? 2 AST-P586BIOMERIEUX, INC2016-06-23
VITEK 2 GRAM-NEGATIVE SUSCEPTABILITY TEST KITBIOMERIEUX, INC.2014-05-12
VITEK 2 GRAM-NEGATIVE SUSCEPTIBILITY TEST KITBIOMERIEUX, INC.2014-05-07
VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KITBIOMERIEUX, INC.2014-04-23
VITEK2BIOMERIUEX2010-02-22
VITEK SYSTEMBIOMERIEUX, INC.2009-07-27
VITEK 2 SYSTEMBIOMERIEUX, INC.2008-03-24
GN 172007-05-18
GN 132007-05-18
GN 09BIOMERIEUX2007-05-18
VITEK 2 SUSCEPTIBILITY CARD, AST-N045BIOMERIEUX, INC.2006-06-30
SUSCEPTIBILITY CARDVITEK SYSTEMS, INC.1994-03-04
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