Product Code: LON


Products Classified as LON

3432System, Test, Automated, Antimicrobial Susceptibility, Short IncubationFully Automated Short-term Incubation Cycle Antimicrobial Susceptibility System.

Total Product Life Cycle (TPLC) Devices

3432System, Test, Automated, Antimicrobial Susceptibility, Short IncubationFully Automated Short-term Incubation Cycle Antimicrobial Susceptibility System.

FDA Consensus Standards

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation [38133]21 CFR §866.1645 🔎
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation [37758]21 CFR §866.1645 🔎
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation [37762]21 CFR §866.1645 🔎
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation [37761]21 CFR §866.1645 🔎
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation [37757]21 CFR §866.1645 🔎

Pre-market Approvals for LON

N50524AUTOBAC MIC TEST SYSTEMORGANON TEKNIKA CORP.
P870049MICROSCAN(R) RAPID FLUOROGENIC PANELSDADE INTL., INC.

Pre-market Notifications for LON

K220805VITEK 2 AST-Gram Positive Cefoxitin ScreenBioMerieux, Inc
K220546Colibrí SystemCopan WASP S.r.l.
K214023VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)BioMerieux, Inc
K213931VITEK 2 AST-Gram Negative Omadacycline (=16 µg/mL)BioMerieux, Inc.
K213241VITEK 2 AST-Yeast Fluconazole (=64 µg/mL), VITEK 2 AST-YS Fluconazole (=64 µg/mL), VITEK 2 AST-YS FluconazoleBioMerieux, Inc.
K212849VITEK 2 AST-Gram Positive Linezolid (=8 µg/mL)BioMérieux, Inc
K210287VITEK 2 AST- Streptococcus Cefotaxime (8 Ug/mL)BioMerieux, Inc
K201675VITEK 2 AST-Gram Negative Meropenem (=16 µg/mL)BioMerieux, Inc.
K201405LabPro Data Management SystemBeckman Coulter Inc.
K193567VITEK 2 AST- Gram Negative Polymyxin B (=16 Ug/mL)BioMerieux, Inc.
K193572VITEK 2 AST-Gram Negative Imipenem/Relebactam (=16/4 µg/mL)BioMerieux, Inc.
K192110Vitek DensichekBioMerieux, Inc
K191766VITEK 2 AST-Gram Negative Eravacycline (=4µg/mL)BioMerieux, Inc.
K190905BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)Becton, Dickinson And Company
K190616VITEK 2 AST-Gram Positive Dalbavancin (= 1 µg/mL)BioMerieux, Inc.

Global Unique Device Identification Database

00382904481056SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
00382904481001SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
00382904436247SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904488711SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904488032SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904488025SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487448SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487431SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487424SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487417SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487387SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487349SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487332SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487325SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
30382904487301SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Maude Adverse Events

VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-27
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-27
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-27
VITEK? 2 AST-P580 TEST KITBIOMERIEUX, INC.2020-03-27
VITEK? 2 AST-P580 TEST KITBIOMERIEUX, INC.2020-03-27
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-GP67 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-GP67 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-N375 TEST KITBIOMERIEUX, INC.2020-03-26
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
BD PHOENIX? NMIC-402BECTON, DICKINSON & CO.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-24
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-23
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-23
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-23
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-23
VITEK? 2 AST-P652 TEST KITBIOMERIEUX INC.2020-03-23
VITEK? 2 AST-P652 TEST KIT2020-03-23
VITEK? 2 AST-N223 TEST KITBIOMERIEUX, INC.2020-03-20
VITEK? 2 AST-GP67 TEST KITBIOMERIEUX, INC.2020-03-20
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-19
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-19
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-19
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-19
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-19
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-19
VITEK? 2 AST-GP78 TEST KITBIOMERIEUX, INC.2020-03-18
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-17
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-17
VITEK? 2 AST-P652 TEST KITBIOMERIEUX, INC.2020-03-17
VITEK? 2 AST-P626 TEST KITBIOMERIEUX, INC.2020-03-17
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