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U.S. Department of Health and Human Services

Product Classification

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Device second antibody (species specific anti-animal gamma globulin)
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeKTS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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