Device Directory
Browse 29 FDA-cleared medical devices
BOND MMR Antibody Panel (K213348)
Class Class II K213348 PZJ
Quantia IgE (K214068)
Class Class II K214068 DGC
Idylla MSI Test (K211181)
Class Class II K211181 PZJ
Traumatic brain injury (TBI) test (K223602)
Class Class II K223602 QAT
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C (K203245)
Class Class II K203245 MMW
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348)
Class Class II K231348 QSE
GlutenID Celiac Genetic Health Risk Test (K241456)
Class Class II K241456 PTA
Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220)
Class Class II K241220 DFC
K-ASSAY CRP (Ver.2) (K242170)
Class Class II K242170 DCK
NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow’s Milk (Bos taurus); NOVEOS Immunoassay Analyz (K242531)
Class Class II K242531 DHB
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