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Microbiology / Immune system / Viruses / Glycoproteins / Inbios / Virology / ELISA / West Nile virus / Immunoglobulin M / Biology / Medicine / Immunologic tests


` 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number:
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Document Date: 2012-04-11 15:52:34

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City

Villanova / /

Company

IgG / InBios International Inc. / /

Continent

Asia / Africa / /

Country

United States / /

Event

FDA Phase / /

Holiday

between day / /

IndustryTerm

diagnostic algorithm / acidic stopping solution / predicate device / /

MedicalCondition

Hepatitis A / Dengue virus infection / Legionnaire’s Disease / Leptospirosis / several different diseases / JE / HIV / Dengue virus. b One leptospirosis / disease / headache / Malaria / Japanese Encephalitis / Hepatitis C / Hepatitis B / InBios DENV Detect IgM Capture ELISA Cross-reactivity Disease / fever / dengue hemorrhagic fever / Dengue virus / Varicella zoster virus / diseases / samples Eastern Equine Encephalitis / Lyme Disease / Legionnaires’ Disease / infectious agent Number / Dengue / Saint Louis encephalitis / Dengue infection / /

Organization

Public Health Lab / /

Person

DENV PRNT / /

Product

EP7-A2 / /

ProvinceOrState

Texas / Florida / /

Region

central U.S. / Caribbean / Southern US / Western United States / Southeast Asia / West Nile / /

Technology

antibodies / CDC MAC ELISA protocol / diagnostic algorithm / /

URL

http /

SocialTag