Appendix D Regulatory notices
48
Osmo1™ Single-Sample Micro-Osmometer Service Guide
Regulatory
approval type Description
USFDA Listing
The Osmo1 and the calibrators and controls manufactured by Advanced Instruments are listed with the U.S.
Department of Health and Human Services, Food and Drug Administration, as:
• Osmometer Class 1
• Calibrators Class 1
• Controls Class 1
Health Canada
The Osmo1 and the calibrators and controls manufactured by Advanced Instruments are licensed with Health
Canada, Therapeutic Products Directorate, Medical Devices Bureau, as:
• Osmo1 Class 2
• Calibrators Class 2
• Controls Class 2
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