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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name device to detect antibodies to hepatitis d virus
De Novo Number DEN250032
Device Name LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
Requester
diasorin, inc.
1951 northwestern ave.
stillwater,  MN  55082
Contact kerrie oetter
Regulation Number866.3176
Classification Product Code
SGW  
Date Received07/30/2025
Decision Date 12/23/2025
Decision granted (DENG)
Classification Advisory Committee Immunology
Review Advisory Committee Microbiology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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