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Technology / Premarket approval / Center for Devices and Radiological Health / Medical device / Federal Food / Drug / and Cosmetic Act / Hepatitis B / Title 21 of the Code of Federal Regulations / Adverse event / Adefovir / Medicine / Food and Drug Administration / Health


P080026 Abbott RealTime HBV Assay
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Document Date: 2013-12-05 19:51:03

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File Size: 194,28 KB

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City

Rockville / Des Plaines / /

Company

Regulatory Abbott Molecular Inc. / /

Currency

pence / /

Event

FDA Phase / /

IndustryTerm

Internet HomePage / similar device / malfunctioned and such device / diagnostic devices / blood products / /

MedicalCondition

HBV infection / HBV / chronic HBV infection / serious injury / /

MedicalTreatment

anti-viral therapy / /

Organization

Microbiology Devices Office / Radiological Health PMA Document Mail Center / Food and Drug Administration / Center for Devices and Radiological Health / Radiological Health / New Hampshire Avenue Document Mail Center / U.S. Food and Drug Administration Center for Devices / DEPARTMENT OF HEALTH / Center for Devices / /

Person

Sally Hojvat / Irene Powers / Silver Spring / /

/

Position

Director / Abbott RealTime HBV Assay Calibrator / Ph.D Director Division / /

Product

W066-G609 / PMA supplement / /

ProvinceOrState

Maryland / Illinois / /

Technology

http / /

URL

www.fda / http /

SocialTag