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U.S. Department of Health and Human Services

Product Classification

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Device assay, endotoxin activity, chemiluminescent
Regulation Description Endotoxin assay.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNGS
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3210
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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