| 2025-09-25 |
K252062 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL |
JWY |
— |
— |
| 2025-09-05 |
K250575 |
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 |
JWY |
— |
— |
| 2025-08-28 |
K252014 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL |
JWY |
— |
— |
| 2025-06-30 |
K250990 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL |
JWY |
— |
— |
| 2025-06-20 |
K242843 |
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. |
JWY |
— |
— |
| 2025-05-22 |
K242659 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL |
JWY |
— |
— |
| 2025-04-15 |
K242658 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL |
JWY |
— |
— |
| 2025-02-27 |
K243738 |
The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL |
NGZ |
Class II |
Microbiology |
| 2025-02-10 |
K243201 |
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 |
JWY |
— |
— |
| 2025-02-10 |
K242905 |
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 |
JWY |
— |
— |
| 2024-12-19 |
K243169 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL |
JWY |
— |
— |
| 2024-12-05 |
K242653 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL |
JWY |
— |
— |
| 2024-11-26 |
K242657 |
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL |
JWY |
— |
— |
| 2024-10-09 |
K242021 |
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. |
JWY |
— |
— |
| 2024-10-01 |
K241967 |
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. |
JWY |
— |
— |
| 2024-05-16 |
K240445 |
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. |
JWY |
— |
— |
| 2023-10-31 |
K232310 |
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 |
JWY |
— |
— |
| 2023-08-31 |
K231433 |
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL |
NGZ |
Class II |
Microbiology |
| 2023-08-30 |
K231988 |
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml |
JWY |
— |
— |
| 2023-08-25 |
K231994 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL |
JWY |
— |
— |
| 2023-06-30 |
K230935 |
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) |
JWY |
— |
— |
| 2023-03-21 |
K223844 |
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) |
JWY |
— |
— |
| 2023-03-10 |
K221198 |
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL |
NGZ |
Class II |
Microbiology |
| 2023-01-20 |
K221899 |
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml |
NGZ |
Class II |
Microbiology |
| 2021-12-20 |
K203741 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml |
JWY |
— |
— |
| 2021-12-15 |
K211539 |
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL |
NGZ |
Class II |
Microbiology |
| 2021-07-23 |
K202612 |
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) |
JWY |
— |
— |
| 2020-03-12 |
K193538 |
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml |
JWY |
— |
— |
| 2020-01-08 |
K193024 |
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL |
JWY |
— |
— |