Device Directory
Browse 29 FDA-cleared medical devices
Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (K243776)
Class Class II K243776 MOB
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706)
Class Class II K242706 SET
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549)
Class Class II K250549 DFH
APO-Easy Genotyping kit (DEN240032)
Class Class II DEN240032 SFC
Atellica IM Thyroglobulin (Tg) (K242981)
Class Class II K242981 MSW
Alegria Flash ENA Screen (K250408)
Class Class II K250408 LLL
Francisella tularensis Real-time PCR assay (K252072)
Class Class II K252072 SGA
Elecsys Phospho-Tau (181P) Plasma (K252163)
Class Class II K252163 SET
ADVIA Centaur Anti-Thyroid Peroxidase II (K250250)
Class Class II K250250 JZO
Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (K250159)
Class Class II K250159 SGG
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