Prescription Use Blood Glucose Meter For Near-Patient Testing
Medical specialty
Clinical Chemistry
Device class
2
Regulation number
862.1345
Review panel
CH
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia.