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Prescription Use Blood Glucose Meter For Near-Patient Testing

FDA product code PZI · 11 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1345
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-01-27 – 2026-06-12

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.

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