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4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
108
results for "Hardy Diagnostics"
Cleared
Nov 20, 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
Hardy Diagnostics
Microbiology
57d
Cleared
Jun 26, 2025
HardyDisk AST Gepotidacin 10µg (GEP10)
Hardy Diagnostics
Microbiology
87d
Cleared
May 15, 2025
HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
Hardy Diagnostics
Microbiology
86d
Cleared
Aug 02, 2024
Viral Transport Medium
Hardy Diagnostics
Microbiology
273d
Cleared
Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
Hardy Diagnostics
Microbiology
91d
Cleared
Jul 06, 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
Hardy Diagnostics
Microbiology
36d
Cleared
Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
Hardy Diagnostics
Microbiology
66d
Cleared
Jan 23, 2020
HardyDisk AST Cefiderocol 30ug (FDC30)
Hardy Diagnostics
Microbiology
36d
Cleared
Sep 19, 2019
HardyDisk AST Lefamulin 20µg (LMU20)
Hardy Diagnostics
Microbiology
23d
Cleared
Jul 31, 2019
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
Hardy Diagnostics
Microbiology
12d
Cleared
Apr 29, 2019
HardyCHROM CRE
Hardy Diagnostics
Microbiology
55d
Cleared
Jan 18, 2019
HardyDisk AST Omadacycline 30µg (OMC30)
Hardy Diagnostics
Microbiology
52d
Cleared
Sep 26, 2018
HardyDisk AST Eravacycline 20µg (ERV20)
Hardy Diagnostics
Microbiology
27d
Cleared
Jul 10, 2018
HardyDisk AST Plazomicin 30ug (PLZ30)
Hardy Diagnostics
Microbiology
13d
Cleared
Mar 22, 2018
Granada Medium
Hardy Diagnostics
Microbiology
90d
Cleared
Oct 03, 2017
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)
Hardy Diagnostics
Microbiology
33d
Cleared
Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
Hardy Diagnostics
Microbiology
32d
Cleared
May 22, 2017
Strep B Carrot Broth One-Step
Hardy Diagnostics
Microbiology
83d
Cleared
May 16, 2017
Strep B Carrot Broth Kit
Hardy Diagnostics
Microbiology
89d
Cleared
Mar 14, 2017
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
Hardy Diagnostics
Microbiology
60d
Cleared
Nov 15, 2016
HardyCHROM ESBL
Hardy Diagnostics
Microbiology
265d
Cleared
Nov 24, 2015
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40
Hardy Diagnostics
Microbiology
56d
Cleared
Nov 24, 2015
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50
Hardy Diagnostics
Microbiology
56d
Cleared
May 04, 2011
HARDYCHROM MRSA
Hardy Diagnostics
Microbiology
215d