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U.S. Department of Health and Human Services

Product Classification

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Device diabetes take home kit
Definition Diabetes take home kit
Physical State n/a
Technical Method n/a
Target Area n/a
Review Panel General Hospital
Product CodeOSS
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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