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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Radiation Therapy Marking Device
FDA classification
FDA Class 2
·Radiation Therapy Marking Device
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
FDA Enforcement
Class III
·Terminated·Critical Diagnostics·July 25, 2012
PHYSICIAN RECOMMENDED NUTRICEUTICALS PRN
FDA registration
PHYSICIAN RECOMMENDED NUTRICEUTICALS PRN·5 products·🇺🇸 United States
Cognition Snapshot v2.0
FDA UDI
Qr8 Health Inc·00860007318719·
MSPT Web v3.0
FDA UDI
Qr8 Health Inc·00195893329458·
Cognition Chronicle v2.1
FDA UDI
Qr8 Health Inc·00860007318764·
Cognition Chronicle v2.0
FDA UDI
Qr8 Health Inc·00860007318795·
MSPT Web v3.1.0
FDA UDI
Qr8 Health Inc·00860011850915·
Cognition Snapshot+ 2.2.0
FDA UDI
Qr8 Health Inc·00860007318757·
Cognition Snapshot+ 2.1.0
FDA UDI
Qr8 Health Inc·00860007318740·
Cognition Snapshot+ 2.3.0
FDA UDI
Qr8 Health Inc·00860007318771·
MSPT v3.1.1
FDA UDI
Qr8 Health Inc·00860011850908·
Chronicle Web
FDA UDI
Qr8 Health Inc·00860007318726·
Cognition Snapshot+ v2.4
FDA UDI
Qr8 Health Inc·00860011850922·
MSPT v3.0
FDA UDI
Qr8 Health Inc·00195893702190·
Chronicle Web v2.0
FDA UDI
Qr8 Health Inc·00860007318788·
Cognition Chronicle
FDA UDI
Qr8 Health Inc·00860007318733·
Cognition Snapshot
FDA UDI
Qr8 Health Inc·00860007318702·
PlasmaRef ARN
FDA UDI
R 2 DIAGNOSTICS, INC.·10859394006177·Assayed Reference Plasma 10 x 1 ml
BD ALARIS IV INFUSION PUMP
FDA Adverse Event
Malfunction
·BD ALARIS/CAREFUSION 303, INC.·Product code FRN·January 12, 2021