Susceptibility Test Discs, Antimicrobial

FDA product code JTN · 328 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.1620
Review panel: MI
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-16 – 2026-08-20

JTN 2026-08-20

HardyDisk AST Tebipenem 10µg (TBP10)

Applicant Hardy Diagnostics

K number K262113

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JTN 2026-07-24

Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60

Applicant Thermo Fisher Scientific (Oxoid Ltd.)

K number K261781

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JTN 2026-07-23

Gepotidacin GEP 10 µg

Applicant Liofilchem, Inc.

K number K261853

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JTN 2026-05-11

HardyDisk AST Gepotidacin 10µg (GEP10)

Applicant Hardy Diagnostics

K number K260842

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JTN 2025-12-05

Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10

Applicant Thermo Fisher Scientific (Oxoid Ltd.)

K number K251337

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JTN 2025-11-20

HardyDisk AST Cefiderocol 30µg (FDC30)

Applicant Hardy Diagnostics

K number K253105

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JTN 2025-08-12

Sulopenem SPM 2 µg

Applicant Liofilchem

K number K251879

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JTN 2025-06-26

HardyDisk AST Gepotidacin 10µg (GEP10)

Applicant Hardy Diagnostics

K number K250956

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JTN 2025-06-23

Ceftobiprole BPR 5 µg Disc

Applicant Liofilchem, Inc.

K number K250885

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JTN 2025-06-12

Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50

Applicant Thermo Fisher Scientific (Oxoid Ltd.)

K number K250789

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JTN 2025-05-15

HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)

Applicant Hardy Diagnostics

K number K250454

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JTN 2024-07-18

HardyDisk AST Cefiderocol 30µg (FDC30)

Applicant Hardy Diagnostics

K number K241060

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JTN 2024-03-22

Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K number K231806

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JTN 2023-10-06

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K number K232276

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JTN 2023-07-06

HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)

Applicant Hardy Diagnostics

K number K231568

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JTN 2023-06-07

BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)

Applicant Becton, Dickinson and Company

K number K230651

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JTN 2023-06-01

HardyDisk AST Rezafungin 5µg (RZF5)

Applicant Hardy Diagnostics

K number K230827

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JTN 2022-12-21

BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)

Applicant Becton, Dickinson and Company

K number K221826

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JTN 2022-09-15

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K number K203336

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JTN 2021-10-27

Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K number K210873

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JTN 2021-07-30

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K number K203700

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JTN 2020-12-04

Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K number K193508

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JTN 2020-01-23

HardyDisk AST Cefiderocol 30ug (FDC30)

Applicant Hardy Diagnostics

K number K193504

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JTN 2019-09-19

HardyDisk AST Lefamulin 20µg (LMU20)

Applicant Hardy Diagnostics

K number K192326

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JTN 2019-07-31

HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)

Applicant Hardy Diagnostics

K number K191931

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JTN 2019-01-18

HardyDisk AST Omadacycline 30µg (OMC30)

Applicant Hardy Diagnostics

K number K183298

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JTN 2018-09-27

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K number K181975

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JTN 2018-09-26

HardyDisk AST Eravacycline 20µg (ERV20)

Applicant Hardy Diagnostics

K number K182357

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JTN 2018-07-10

HardyDisk AST Plazomicin 30ug (PLZ30)

Applicant Hardy Diagnostics

K number K181700

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JTN 2017-10-03

HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)

Applicant Hardy Diagnostics

K number K172621

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JTN 2017-08-01

HardyDisk AST Delafloxacin 5 µg (DLX5)

Applicant Hardy Diagnostics

K number K171975

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JTN 2017-03-14

HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40

Applicant Hardy Diagnostics

K number K170127

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JTN 2011-10-18

CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)

Applicant Becton, Dickinson and Company (BD)

K number K112586

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JTN 2010-12-17

HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939

Applicant Hardy Diagnostics

K number K103538

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JTN 2010-03-29

TELAVANCIN 30 UG, BBL SENSI-DISC

Applicant Becton, Dickinson and Company

K number K100722

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JTN 2010-01-08

HARDYDISK AST TELAVANCIN,30UG

Applicant Hardy Diagnostics

K number K093807

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JTN 2008-10-06

FLUCONAZOLE 25UG BBL SENSI-DISC

Applicant Becton, Dickinson & CO

K number K082271

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JTN 2008-10-02

VORICONAZOLE 1UG BBL SENSI-DISC

Applicant Becton, Dickinson & CO

K number K082272

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JTN 2008-05-12

DORIPENEM 10UG BBL SENSI-DISC

Applicant Becton, Dickinson & CO

K number K080998

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JTN 2008-01-29

HARDYDISK AST DORIPENEM 10 UG

Applicant Hardy Diagnostics

K number K080019

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JTN 2007-03-14

ERTAPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Applicant Oxoid , Ltd.

K number K070262

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JTN 2006-08-23

HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936

Applicant Hardy Diagnostics

K number K062245

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JTN 2006-03-17

TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Applicant Oxoid , Ltd.

K number K060286

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JTN 2005-11-17

TIGECYCLINE 15UG BBL SENSI-DISC

Applicant Becton, Dickinson & CO

K number K052853

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JTN 2005-11-14

TELITHROMYCIN 15UG BBL SENSI-DISC

Applicant Becton, Dickinson & CO

K number K052876

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JTN 2005-02-10

GEMIFLOXACIN, 5UG BBL SENSI-DISC

Applicant Becton, Dickinson & CO

K number K050062

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JTN 2004-09-14

DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Applicant Oxoid , Ltd.

K number K042157

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JTN 2002-05-15

ERTAPENEM 10UG BBL SENSI-DISC

Applicant Becton, Dickinson & CO

K number K020842

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JTN 2001-06-13

HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883

Applicant Hardy Diagnostics

K number K011384

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JTN 2001-05-18

HARDKYDISK NEOMYCIN, 30 MCG

Applicant Hardy Diagnostics

K number K011385

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JTN 2001-04-26

HARDYDISK BACITRACIN, 10MCG, MODEL Z927

Applicant Hardy Diagnostics

K number K011086

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JTN 2001-04-24

LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Applicant Oxoid , Ltd.

K number K010537

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JTN 2001-04-24

MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Applicant Oxoid , Ltd.

K number K010536

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JTN 2001-01-25

HARDYDISK SULFISOXAZOLE

Applicant Hardy Diagnostics

K number K003690

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JTN 2001-01-19

HARDYDISK TRIMETHOPRIM 5MCG

Applicant Hardy Diagnostics

K number K003554

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JTN 2001-01-17

HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG

Applicant Hardy Diagnostics

K number K003556

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JTN 2001-01-12

HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG

Applicant Hardy Diagnostics

K number K003686

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JTN 2001-01-12

HARDYDISK RIFAMPIN, 5MCG

Applicant Hardy Diagnostics

K number K003537

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JTN 2001-01-12

HARDYDISK NAFCILLIN, 1 MCG

Applicant Hardy Diagnostics

K number K003536

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JTN 2000-12-13

HARDY DISK, CEFPODOXINE, 10MCG

Applicant Hardy Diagnostics

K number K003532

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JTN 2000-11-02

HARDYDISK CLINDAMYCIN, 2MCG

Applicant Hardy Diagnostics

K number K002662

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JTN 2000-10-26

HARDYDISK LEVOFLOXACIN, 5MCG

Applicant Hardy Diagnostics

K number K002664

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JTN 2000-10-26

HARDYDISK CEFOTETAN, 30MCG

Applicant Hardy Diagnostics

K number K002661

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JTN 2000-10-26

HARDYDISK LOMEFLOXACIN, 10MCG

Applicant Hardy Diagnostics

K number K002660

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JTN 2000-10-26

HARDYDISK GENTAMICIN, 120MCG

Applicant Hardy Diagnostics

K number K002369

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JTN 2000-10-26

HARDY DISK CEFTIZOXIME, 30MCG

Applicant Hardy Diagnostics

K number K002367

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JTN 2000-10-25

HARDYDISK CEFUROXIME, 30MCG

Applicant Hardy Diagnostics

K number K002656

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JTN 2000-10-25

HARDYDISK STREPTOMYCIN, 300MCG

Applicant Hardy Diagnostics

K number K002368

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JTN 2000-10-19

HARDYDISK NETILMICIN, 30MCG

Applicant Hardy Diagnostics

K number K002663

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JTN 2000-09-05

LINEZOLID, 30UG, BBL SENSI-DISC

Applicant Dickinson, and Co.

K number K002165

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JTN 2000-07-27

HARDY DISK CLARITHROMYCIN, 15MCG

Applicant Hardy Diagnostics

K number K001728

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JTN 2000-06-07

HARDYDISK CINOXACIN, 100 MCG

Applicant Hardy Diagnostics

K number K001487

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JTN 2000-06-01

HARDYDISK CEFONICID, 30 MCG

Applicant Hardy Diagnostics

K number K001490

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JTN 2000-06-01

HARDYDISK CEFOPERAZONE, 75 MCG

Applicant Hardy Diagnostics

K number K001489

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JTN 2000-05-22

GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Applicant Oxoid , Ltd.

K number K000930

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JTN 2000-05-15

QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Applicant Oxoid , Ltd.

K number K000928

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JTN 2000-04-25

MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K000762

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JTN 2000-04-13

GATIFLOXACIN, 5 UG, BBL SENSI-DISC

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K000829

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JTN 2000-04-13

HARDYDISK, CEPHALOTHIN 30MCG

Applicant Hardy Diagnostics

K number K000526

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JTN 2000-04-07

HARDYDISK OFLOXACIN 5MCG

Applicant Hardy Diagnostics

K number K000525

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JTN 2000-04-07

HARDYDISK, CEFOTAXIME 30MCG

Applicant Hardy Diagnostics

K number K000524

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JTN 2000-04-07

HARDYDISK, VANCOMYCIN 30MCG

Applicant Hardy Diagnostics

K number K000509

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JTN 2000-04-07

HARDYDISK CEFTRIAXONE 30MCG

Applicant Hardy Diagnostics

K number K000440

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JTN 2000-04-07

HARDYDISK, NITROFURANTOIN

Applicant Hardy Diagnostics

K number K000272

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JTN 2000-04-07

HARDYDISK, SULFA/TRIMETH

Applicant Hardy Diagnostics

K number K000271

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JTN 2000-04-07

HARDYDISK, AMPICILLIN, 10MCG

Applicant Hardy Diagnostics

K number K000268

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JTN 2000-04-07

HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG

Applicant Hardy Diagnostics

K number K000261

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JTN 2000-03-31

HARDYDISK, CEFOXITIN, 30MCG

Applicant Hardy Diagnostics

K number K000305

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JTN 2000-03-29

HARDYDISK, TETRACYCLINE 30MCG

Applicant Hardy Diagnostics

K number K000304

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JTN 2000-03-24

HARDY DISK, PENICILLIN, 10 UNITS

Applicant Hardy Diagnostics

K number K000302

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JTN 2000-03-21

HARDYDISK, CEFTAZIDIME, 30MCG

Applicant Hardy Diagnostics

K number K000259

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JTN 2000-03-21

HARDYDISK, CIPROFLOXACIN, 5MCG

Applicant Hardy Diagnostics

K number K000258

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JTN 2000-03-21

HARDYDISK, KANAMYCIN, 30MCG

Applicant Hardy Diagnostics

K number K000203

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JTN 2000-03-02

HARDYDISK, CARBENICILLIN, 100MCG

Applicant Hardy Diagnostics

K number K000181

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JTN 2000-03-02

HARDYDISK TICARILLIN 75MCG

Applicant Hardy Diagnostics

K number K000175

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JTN 2000-02-29

HARDYDISK, STREPTOMYCIN 10MCG

Applicant Hardy Diagnostics

K number K000201

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JTN 2000-02-29

HARDYDISK TOBRAMYCIN, 10MCG

Applicant Hardy Diagnostics

K number K000182

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JTN 2000-02-29

HARDYDISK, NALIDIXIC ACID, 30MCG

Applicant Hardy Diagnostics

K number K000130

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JTN 2000-02-28

HARDYDISK, PIPERACILLIN, 100MCG

Applicant Hardy Diagnostics

K number K000183

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JTN 2000-02-18

HARDYDISK, CEFAZOLIN, 30MCG

Applicant Hardy Diagnostics

K number K000128

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