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U.S. Department of Health and Human Services

Product Classification

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Device hyaline membrane disease assay
Review Panel Clinical Chemistry
Product CodeLTC
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Contact ODE
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible