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Biology / Immunologic tests / JC virus / Viruses / Progressive multifocal leukoencephalopathy / Natalizumab / Immunoassay / Polyomaviridae / Center for Devices and Radiological Health / Medicine / Health / Food and Drug Administration


Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: In Vitro diagnostic devices for JCV antibody detection
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Company

IgG / In Vitro Diagnostics / Radiological / /

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IndustryTerm

predicate device / to your device / non-standard equipment / nucleic acid amplification devices / marketed device / /

MedicalCondition

lytic infection / disease / strain / JCV infection / progressive multifocal leukoencephalopathy / multiple sclerosis / rare demyelinating disease / prior infection / Infections / /

MedicalTreatment

biologic therapies / /

Organization

Radiological Health Office / U.S. Department of Health and Human Services / Division of Microbiology Devices / Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health Division of Microbiology Devices Preface Public Comment You / Division of Dockets Management / Food and Drug Administration Center for Devices / Radiological Health / /

Person

John Cunningham Virus Serological Reagents / Mubarak / Marina Kondratovich / /

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Position

Governor / physician / General / /

Technology

antibodies / /

URL

http /

SocialTag