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Microbiology / Viral diseases / Glycoproteins / Immune system / HIV/AIDS / Human T-lymphotropic virus / HIV / Adult T-cell leukemia/lymphoma / Tropical spastic paraparesis / Biology / Medicine / Sexually transmitted diseases and infections


Summary Basis for Regulatory Action: Human T-Lymphotropic Virus Types I & II
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City

Santa Ana / /

Company

IgG / HTLV-I & HTLV-II Inconclusive Ab / Babatunde D. Babalola Lot Release Review Software / I. Introduction MP Biomedicals Asia Pacific Pte. Ltd. / IFA Ab / Public Health Laboratory / MP Biomedicals Asia Pacific Pte. Ltd. / NITROCELLULOSE STRIPS Incorporated / MP Biomedicals LLC / M.D. / /

Country

United States / /

Event

FDA Phase / Product Issues / /

IndustryTerm

laboratory-developed testing algorithm / gene product / gene products / transfusible blood products / contaminated blood products / env gene product / gag gene product / /

MedicalCondition

hairy T-cell leukemia / HTLV-II infections / HTLV-associated uveitis / disease / HTLV-II infection / HTLV type-II infections / HTLV-Associated Myelopathy/Tropical Spastic Paraparesis / severe hematological and neurological diseases / adult T-cell leukemia/lymphoma / infection / infections / /

MedicalTreatment

counseling / /

MusicGroup

HTLV / /

Organization

Offices Signatory Authority / CDPHL WB / Approval Offices Signatory Authority / U.S. Public Health Service / Center for Disease Control / FDA / D. California Department of Public Health Laboratory Testing Algorithm In / tested using a CDPHL WB / /

Person

Jay S. Epstein / Erin Mcdowell Labeling / ELISA RR / Jennifer Schmidt / Mary Malarkey / Kori Francis / Stephen Kerby / Dana Martin / Cherie Ward-Peralta / Susan Zullo Hilary Hoffman / Richard Coats / Thomas J. Maruna / Pradip N. Akolkar / /

Position

OCTGT Review Karoll Cortez Regulatory Project Manager / Director / OCBQ /CBER / Director / OBRR /CBER / MP / WB / HTLV WB / /

Product

Pyle P32 Television / HTLV-I / blood products B. HTLV Testing / HTLV-I/II RR / /

ProvinceOrState

California / /

Technology

laboratory-developed testing algorithm / antibodies / /

SocialTag