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U.S. Department of Health and Human Services

Product Classification

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Device alpha-1-antitrypsin kit, qualitative phenotype
Regulation Description Alpha-1-antitrypsin immunological test system.
Definition The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings.For in vitro diagnostic use only.
Physical State A1AT Antibody Isoelectric focusing gel qualitative phenotype kit and A1AT qualitative phenotype control
Technical Method Isoelectric focusing gel qualitative test.
Target Area Blood serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOBZ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5130
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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