Product Code: JWY


Products Classified as JWY

3375Manual Antimicrobial Susceptibility Test SystemsAntimicrobial Susceptibility Test Powder.

Total Product Life Cycle (TPLC) Devices

3375Manual Antimicrobial Susceptibility Test SystemsAntimicrobial Susceptibility Test Powder.

FDA Consensus Standards

Manual Antimicrobial Susceptibility Test Systems [38133]21 CFR §866.1640 🔎
Manual Antimicrobial Susceptibility Test Systems [30228]21 CFR §866.1640 🔎
Manual Antimicrobial Susceptibility Test Systems [37758]21 CFR §866.1640 🔎
Manual Antimicrobial Susceptibility Test Systems [37762]21 CFR §866.1640 🔎
Manual Antimicrobial Susceptibility Test Systems [37761]21 CFR §866.1640 🔎
Manual Antimicrobial Susceptibility Test Systems [37757]21 CFR §866.1640 🔎
Manual Antimicrobial Susceptibility Test Systems [38170]21 CFR §866.1640 🔎
Manual Antimicrobial Susceptibility Test Systems [38869]21 CFR §866.1640 🔎

Pre-market Notifications for JWY

K211672MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mLLiofilchem S. R. L.
K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)BioMerieux SA
K202612Sensititre 20-24 Hour Haemophilus Influenzae /Streptococcus Pneumoniae MIC Or Breakpoint Susceptibility System With Dtest (containing Erythromycin At 1 Ug/mL And Clindamycin At 0.5 Ug/mL)Thermo Fisher Scientific
K200512ETEST Plazomicin (PLZ) (0.016-256 µg/mL)BioMérieux S.A.
K200308MTS Lefamulin 0.016- 256 µg/mLLiofilchem S. R. 1.
K200180MTS Omadacycline 0.002 - 32 Ug/mLLiofilchem S. R. L.
K193538Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Cefiderocol In The Dilution Range Of 0.03-64 µg/mlThermo Fisher Scientific
K193024Sensititre 20-24 Hour Haemophilus Influenzae/Streptococcus Pneumoniae MIC Or Breakpoint, Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/mLThermo Fisher Scientific
K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)BioMerieux SA
K192729Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Lefamulin In The Dilution Range Of 0.008-16ug/mlThermo Fisher Scientific
K192345MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mLLiofilchem S. R. L.
K192355MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem (Mer) (0.004-32ug/mL)Beckman Coulter, Inc.
K192250Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Imipenem-Relebactam In The Dilution Range Of 0.03/4-256/4 Ug/mLThermo Fisher Scientific
K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)BioMerieux SA
K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 Ug/mL)BioMerieux SA

Global Unique Device Identification Database

00822409032976Manual antimicrobial susceptibility test systems
00822409032969Manual antimicrobial susceptibility test systems
00822409032938Manual antimicrobial susceptibility test systems
00822409032891Manual antimicrobial susceptibility test systems
00822409032884Manual antimicrobial susceptibility test systems
00822409032853Manual antimicrobial susceptibility test systems
00822409032839Manual antimicrobial susceptibility test systems
00822409032815Manual antimicrobial susceptibility test systems
00822409032747Manual antimicrobial susceptibility test systems
00822409032716Manual antimicrobial susceptibility test systems
00822409032693Manual antimicrobial susceptibility test systems
00822409032679Manual antimicrobial susceptibility test systems
00822409032662Manual antimicrobial susceptibility test systems
00822409032648Manual antimicrobial susceptibility test systems
00822409032624Manual antimicrobial susceptibility test systems

Maude Adverse Events

ETEST? BENZYLPENICIL PG 32 US S30BIOMERIEUX SA2020-03-27
ETEST? BENZYLPENICIL PG 32 US F100BIOMERIEUX SA2020-03-27
ETEST? BENZYLPENICIL PG 32 US F100BIOMERIEUX SA2020-03-26
ETEST? BENZYLPENICIL PG 32 US F100BIOMERIEUX SA2020-03-26
MEROPENEM MP 32 WW B30 - 513800BIOM?RIEUX, SA2020-03-19
ETEST? MEROEPENEMBIOMERIEUX SA2020-02-28
ETEST? ERTAPENEMBIOMERIEUX SA2020-02-28
ETEST? IMIPENEMBIOMERIEUX SA2020-02-28
ETEST? ERTAPENEM ETP 32 WW B30BIOMERIEUX SA2020-02-19
ETEST? VANCOMYCIN VA 256 WW F100BIOMERIEUX, SA2020-01-02
ETEST? MEROPENEM MP 32 WW B30BIOMERIEUX SA2019-11-20
ETEST? MEROPENEM MP 32 WW B30BIOMERIEUX SA2019-11-20
ETEST? MEROPENEM MP 32 WW B30BIOMERIEUX SA2019-11-20
ETEST? IMIPENEM IP 32 WW S30BIOMERIEUX SA2019-11-20
ETEST? CEFTAZIDIME TZ 256 WW S30BIOMERIEUX SA2019-10-04
ETEST? BENZYLPENICILBIOMERIEUX, SA2019-08-22
ETEST? BENZYLPENICILLIN PG 32 WW F100BIOMERIEUX SA2019-08-09
ETEST? BENZYLPENICILLIN PG 32 WW F100BIOMERIEUX SA2019-08-09
ETEST? BENZYLPENICILLIN PG 32 WW F100BIOMERIEUX SA2019-08-09
ETEST? VANCOMYCIN VA 256 WW S30BIOMERIEUX, SA2018-11-20
ETEST? MEROPENEM MP 32 WW B30BIOMERIEUX, SA2018-11-19
ETEST? IMIPENEM IP 32WW S30BIOMERIEUX, SA2018-11-01
ETEST? BENZYLPENICIL PG 32 WW S30BIOMERIEUX SA2018-09-11
ETEST? VANCOMYCIN VA 256 WW S30BIOMERIEUX SA2018-07-31
ETEST? BENZYLPENICIL PG 32 WW S30BIOMERIEUX SA2018-06-20
ETEST? BENZYLPENICIL PG 32 WW S30BIOMERIEUX SA2018-06-20
ETEST? BENZYLPENICIL PG 32 WW S30BIOMERIEUX SA2018-06-20
ETEST? BENZYLPENICIL PG 32 WW S30BIOMERIEUX SA2018-06-20
ETEST? DAPTOMYCIN DPC 256 WW S30BIOMERIEUX SA2018-05-24
ETEST? CEFTAZIDIME TZ 256 WW S30BIOMERIEUX SA2018-05-10
ETEST? DAPTOMYCIN DPC 256 WW F100BIOMERIEUX SA2018-03-27
ETEST? DAPTOMYCIN DPC 256 WW F100BIOMERIEUX SA2018-03-27
ETEST? CEFTAROLINEBIOMERIEUX SA2017-10-06
UNKNOWN BIOMET OSS BEARINGBIOMET ORTHOPEDICS2017-08-03
ETEST? AMPICILLIN AM 256 WW S30BIOMERIEUX, SA2017-06-30
ETEST? AMIKACINBIOMERIEUX SA2017-06-15
VITEK? 2 AST-N233 TEST KITBIOMERIEUX, INC2017-04-13
ETEST? ERTAPENEM ETP 32 WW B30BIOMERIEUX, SA2017-03-29
ETEST? TICARCILLIN CLAVULANIC ACIDBIOM?RIEUX SA2017-03-29
ETEST? ERTAPENEM ETP 32 WW B30BIOMERIEUX, SA2017-02-23
ETEST? VORICONAZOLEBIOMERIEUX, SA2017-01-06
ETEST? VORICONAZOLEBIOMERIEUX, SA2016-11-08
ETEST? VORICONAZOLEBIOMERIEUX, SA2016-11-08
ETEST? DAPTOMYCIN DPC 256 WW S30BIOMERIEUX, SA2016-05-06
ETEST? DAPTOMYCIN DPC 256 WW S30BIOMERIEUX, SA2016-05-05
ETEST? METRONIDAZOLE MZHBIOMERIEUX, SA2016-05-03
ETEST? METRONIDAZOLE MZHBIOMERIEUX, SA2016-04-28
ETEST? METRONIDAZOLE MZHBIOMERIEUX, SA2016-04-28
ETEST? METRONIDAZOLE MZHBIOMERIEUX, SA2016-04-28
ETEST? CIPROFLOXACIN CI 32 WW F100BIOMERIEUX, SA2016-04-27
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