Manual Antimicrobial Susceptibility Test Systems

FDA product code JWY · 426 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.1640
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-02-10 – 2026-04-21

JWY 2026-04-21

ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

Applicant bioMérieux SA

K number K260447

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JWY 2026-04-17

MTS Gepotidacin 0.016-256 µg/mL

Applicant Liofilchem s.r.l.

K number K260696

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JWY 2025-10-02

MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL

Applicant Liofilchem s.r.l.

K number K252114

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JWY 2025-09-25

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL

Applicant Thermo Fisher Scientific

K number K252062

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JWY 2025-09-05

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL

Applicant Thermo Fisher Scientific

K number K250575

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JWY 2025-08-28

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

Applicant Thermo Fisher Scientific

K number K252014

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JWY 2025-08-20

MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)

Applicant Liofilchem s.r.l.

K number K251580

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JWY 2025-06-30

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL

Applicant Thermo Fisher Scientific

K number K250990

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JWY 2025-06-20

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL.

Applicant Thermo Fisher Scientific

K number K242843

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JWY 2025-06-12

ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

Applicant Biomérieux

K number K250856

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JWY 2025-05-22

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL

Applicant Thermo Fisher Scientific

K number K242659

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JWY 2025-04-30

ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

Applicant Biomerieux S.A.

K number K250274

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JWY 2025-04-15

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL

Applicant Thermo Fisher Scientific

K number K242658

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JWY 2025-02-10

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL

Applicant Thermo Fisher Scientific

K number K243201

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JWY 2025-02-10

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL

Applicant Thermo Fisher Scientific

K number K242905

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JWY 2025-01-30

MTS Ceftobiprole 0.002-32 µg/mL

Applicant Liofilchem s.r.l.

K number K243202

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JWY 2024-12-19

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL

Applicant Thermo Fisher Scientific

K number K243169

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JWY 2024-12-05

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL

Applicant Thermo Fisher Scientific

K number K242653

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JWY 2024-11-26

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL

Applicant Thermo Fisher Scientific

K number K242657

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JWY 2024-10-09

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml.

Applicant Thermo Fisher Scientific

K number K242021

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JWY 2024-10-01

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml.

Applicant Thermo Fisher Scientific

K number K241967

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JWY 2024-05-16

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.

Applicant Thermo Fisher Scientific

K number K240445

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JWY 2023-10-31

Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml

Applicant Thermo Fisher Scientific

K number K232310

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JWY 2023-10-05

ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD

Applicant Biomérieux

K number K232395

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JWY 2023-08-30

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml

Applicant Thermo Fisher Scientific

K number K231988

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JWY 2023-08-25

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL

Applicant Thermo Fisher Scientific

K number K231994

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JWY 2023-06-30

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)

Applicant Thermo Fisher Scientific

K number K230935

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JWY 2023-05-18

ComASP Cefiderocol 0.008-128

Applicant Liofilchem s.r.l.

K number K230479

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JWY 2023-03-21

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)

Applicant Thermo Fisher Scientific

K number K223844

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JWY 2021-12-20

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml

Applicant Thermo Fisher Scientific

K number K203741

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JWY 2021-11-12

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

Applicant Biomerieux S.A.

K number K210757

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JWY 2021-10-20

MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL

Applicant Liofilchem s.r.l.

K number K211672

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JWY 2021-07-23

Sensititre 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)

Applicant Thermo Fisher Scientific

K number K202612

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JWY 2021-05-18

MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)

Applicant Beckman Coulter, Inc.

K number K202423

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JWY 2020-05-07

ETEST Plazomicin (PLZ) (0.016-256 µg/mL)

Applicant Biomérieux SA

K number K200512

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JWY 2020-04-06

MTS Lefamulin 0.016- 256 µg/mL

Applicant Liofilchem S. R. 1.

K number K200308

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JWY 2020-03-20

MTS Omadacycline 0.002 - 32 ug/mL

Applicant Liofilchem s.r.l.

K number K200180

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JWY 2020-03-12

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml

Applicant Thermo Fisher Scientific

K number K193538

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JWY 2020-01-08

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL

Applicant Thermo Fisher Scientific

K number K193024

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JWY 2019-11-26

ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

Applicant Biomerieux S.A.

K number K192738

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JWY 2019-11-14

MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL)

Applicant Beckman Coulter, Inc.

K number K192355

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JWY 2019-11-06

Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml

Applicant Thermo Fisher Scientific

K number K192729

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JWY 2019-10-31

MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL

Applicant Liofilchem s.r.l.

K number K192345

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JWY 2019-10-16

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL

Applicant Thermo Fisher Scientific

K number K192250

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JWY 2019-09-27

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

Applicant Biomerieux S.A.

K number K192050

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JWY 2019-09-04

MTS Imipenem 0.016-256 µg/mL

Applicant Liofilchem s.r.l.

K number K191908

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JWY 2019-08-23

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

Applicant Liofilchem s.r.l.

K number K191809

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JWY 2019-08-22

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

Applicant Biomerieux S.A.

K number K191953

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JWY 2019-05-29

MTS Doxycycline 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K number K190914

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JWY 2019-05-01

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

Applicant Biomerieux S.A.

K number K190154

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JWY 2019-04-18

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

Applicant Beckman Coulter, Inc.

K number K190109

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JWY 2019-03-22

MTS Gentamicin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K number K190252

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JWY 2019-03-19

MTS Ciprofloxacin 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K number K183527

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JWY 2019-02-15

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL

Applicant Thermo Fisher Scientific

K number K183324

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JWY 2019-01-11

MTS Tetracycline 0.016 - 256 ug/mL

Applicant Liofilchem s.r.l.

K number K183140

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JWY 2019-01-11

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

Applicant Biomerieux S.A.

K number K183031

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JWY 2019-01-04

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml

Applicant Thermo Fisher Scientific

K number K183033

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JWY 2018-12-20

MTS Levofloxacin 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K number K183115

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JWY 2018-12-14

MTS Omadacycline 0.002-32 µg/mL

Applicant Liofilchem s.r.l.

K number K182922

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JWY 2018-11-30

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL

Applicant Thermo Fisher Scientific

K number K182797

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JWY 2018-11-02

MTS Eravacycline 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K number K182557

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JWY 2018-09-13

MTS Penicillin 0.002- 32 µg/mL

Applicant Liofilchem s.r.l.

K number K181889

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JWY 2018-08-08

Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL

Applicant Thermo Fisher Scientific

K number K181946

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JWY 2018-07-31

MTS Plazomicin 0.016-256 µg/mL

Applicant Liofilchem s.r.l.

K number K181708

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JWY 2018-07-03

ETEST Telavancin (TLA) (0.002-32 ug/mL)

Applicant Biomerieux S.A.

K number K180936

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JWY 2018-05-18

Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL

Applicant Liofilchem s.r.l.

K number K180886

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JWY 2018-04-04

Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K number K180339

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JWY 2018-03-15

Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL

Applicant Liofilchem s.r.l.

K number K180330

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JWY 2018-02-28

Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL

Applicant Liofilchem s.r.l.

K number K173817

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JWY 2017-12-19

Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL

Applicant Liofilchem s.r.l.

K number K173307

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JWY 2017-12-01

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL

Applicant Thermo Fisher Scientific

K number K173209

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JWY 2017-10-23

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL.

Applicant Liofilchem s.r.l.

K number K172542

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JWY 2017-10-13

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL

Applicant Thermo Fisher Scientific

K number K172454

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JWY 2017-09-27

Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K number K172109

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JWY 2017-09-15

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)

Applicant bioMerieux, Inc.

K number K172150

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JWY 2017-08-30

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL

Applicant Thermo Fisher Scientific

K number K172274

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JWY 2017-08-01

Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K number K171906

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JWY 2017-08-01

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL

Applicant Thermo Fisher Scientific

K number K171870

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JWY 2017-06-07

Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL

Applicant Liofilchem s.r.l.

K number K170772

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JWY 2017-05-31

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

Applicant bioMerieux, Inc.

K number K170670

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JWY 2017-05-25

Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL

Applicant Liofilchem s.r.l.

K number K170892

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JWY 2017-03-14

Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL

Applicant Liofilchem s.r.l.

K number K163517

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JWY 2017-02-22

Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL

Applicant Liofilchem s.r.l.

K number K163298

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JWY 2016-12-19

Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml

Applicant Liofilchem s.r.l.

K number K162854

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JWY 2016-07-12

Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL

Applicant Liofilchem s.r.l.

K number K161175

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JWY 2016-06-22

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

Applicant Liofilchem s.r.l.

K number K153569

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JWY 2016-03-31

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

Applicant Liofilchem s.r.l.

K number K153687

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JWY 2012-10-12

ETEST CEFTAROLINE

Applicant bioMerieux, Inc.

K number K121002

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JWY 2011-11-16

VIZION

Applicant Trek Diagnostic Systems

K number K112276

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JWY 2011-11-08

SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES

Applicant Trek Diagnostic Systems

K number K111615

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JWY 2011-08-18

SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...

Applicant Trek Diagnostic Systems, Ltd.

K number K111429

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JWY 2011-05-16

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

Applicant Biomerieux S.A.

K number K102535

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JWY 2010-11-17

ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

Applicant BIOMERIEUX

K number K102668

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JWY 2010-08-25

ETEST MOXIFLOXACIN 0.002-32 UG/ML

Applicant Ab Biomerieux

K number K093604

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JWY 2010-02-25

SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES

Applicant Trek Diagnostic Systems, Ltd.

K number K093741

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JWY 2010-02-17

SENSITITRE 18-24HR SUSCEPTIBILITY PLATES

Applicant Trek Diagnostic Systems, Inc.

K number K093865

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JWY 2009-12-16

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

Applicant Trek Diagnostic Systems, Ltd.

K number K092445

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JWY 2009-03-24

SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES

Applicant Trek Diagnostic Systems, Inc.

K number K083606

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JWY 2008-10-24

SENSITITRE VIZION

Applicant Trek Diagnostic Systems, Inc.

K number K081520

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JWY 2008-08-08

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN

Applicant Siemens

K number K081182

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