Device Directory
Browse 29 FDA-cleared medical devices
Alegria Flash CTD Screen (K250666)
Class Class II K250666 LLL
ADVIA Centaur Anti-Thyroglobulin II (aTgII) (K250816)
Class Class II K250816 JNL
ADVIA Centaur Cytokeratin Fragment 21-1 (K250925)
Class Class II K250925 OVK
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay (K253358)
Class Class II K253358 DFH
NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) (K252493)
Class Class II K252493 DHB
LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (DEN250032)
Class Class II DEN250032 SGW
Atellica IM Total PSA II (tPSAII) (K251630)
Class Class II K251630 LTJ
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg (K252775)
Class Class II K252775 DHB
Aptiva APS IgA Reagent (K243979)
Class Class II K243979 MSV
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