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U.S. Department of Health and Human Services

Product Classification

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Device device, specimen collection
Regulation Description Microbiological specimen collection and transport device.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLIO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.2900
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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