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Product Approval Information - Licensing Action

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Proper name: Human T-Lymphotropic Virus Types I&II
Tradename: Vironostika HTLV-I/II Microelisa System
Manufacturer: Organon Teknika Corp, Durham, NC, License #956
Indication for Use: In vitro qualitative ELISA assay for use in the detection of antibodies to human T-lymphotropic virus types I and/or II in human serum or plasma
Approval Date: 1/17/98
Type of submission: Product license application

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Approval Letter - (PDF), (Text)

 

Updated March 5, 2001
 
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