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U.S. Department of Health and Human Services

Product Classification

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Device hemoglobin a2 quantitation
Regulation Description Hemoglobin A[bdi2] assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJPD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons