Device Directory
Browse 178 FDA-cleared medical devices
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (K250036)
Class Class II K250036 LTT
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) (K243804)
Class Class II K243804 LTT
MTS Sulbactam-Durlobactam 0.004/4 – 64/4 µg/mL (SUD) (K251580)
Class Class II K251580 JWY
WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test (K251563)
Class Class II K251563 SCA
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (K251579)
Class Class II K251579 LON
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test (K251604)
Class Class II K251604 SCA
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini (K250080)
Class Class II K250080 QOF
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014)
Class Class II K252014 JWY
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 (K250575)
Class Class II K250575 JWY
GenaCheck COVID-19 Rapid Self-Test (K251753)
Class Class II K251753 QYT
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