Device Directory
Browse 178 FDA-cleared medical devices
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (K241317)
Class Class II K241317 QYT
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. (K241967)
Class Class II K241967 JWY
NxTAG® Respiratory Pathogen Panel (K242613)
Class Class II K242613 OCC
Healgen Rapid Check COVID-19/Flu A&B Antigen Test (DEN240029)
Class Class II DEN240029 SCA
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. (K242021)
Class Class II K242021 JWY
PPH Saliva Collection Kit (K240797)
Class Class II K240797 QBD
UriSponge™ (K232565)
Class Class I K232565 JSM
Access Toxo IgM II (K242095)
Class Class II K242095 LGD
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K241324)
Class Class II K241324 SAN
QIAstat-Dx Respiratory Panel Mini (K242353)
Class Class II K242353 QOF
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