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Herpes / Sexually transmitted diseases and infections / Viral diseases / Herpes simplex / Neonatal herpes simplex / HSV-2 / Encephalitis / Medicine / Health / Microbiology


Guidance for Industry and FDA Staff
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City

Rockville / /

Company

IgG / /

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IndustryTerm

predicate device / results based on your new device / nucleic acid amplification devices / precision protocol / /

MedicalCondition

mild infection / herpes simplex viruses / HSV infection / bacterial vaginosis / Neonatal herpes virus infections / HSV infections / herpes / human papilloma virus / simplex viral infections / rubella virus / latent herpes virus infection / encephalitis / diseases / primary herpes infection / Neisseria gonorrhea / inflammation / herpes simplex virus / severe generalized disease / /

Organization

Radiological Health Office / U.S. Department of Health and Human Services / Division of Microbiology Devices / Food and Drug Administration / In Vitro Diagnostic Device Evaluation and Safety Division of Microbiology Devices Preface Public Comment You / Division of Dockets Management / Food and Drug Administration Center for Devices / Centers for Disease Control and Prevention / /

Person

Haja Sittana El Mubarak / /

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Position

Governor / Performance Characteristics General / calibrator / representative / /

Product

sodium heparin / /

ProvinceOrState

Maryland / /

Technology

antibodies / precision protocol / /

URL

http /

SocialTag