FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas
CBER links
horizontal rule

Product Approval Information - Licensing Action

horizontal rule

Proper name: Human Immunodeficiency Virus Type 1 (Western Blot)
Tradename: Cambridge Biotech HIV-1 (Western Blot)
Manufacturer: Cambridge Biotech Corp, Rockville,Maryland, License #1063
Indication for Use: New indication for urine specimen testing
Approval Date: 5/28/98
Type of submission: Product license supplement

horizontal rule

Approval Letter - (Text), (PDF)

SBA (30 pages) - (PDF)

Label (47 pages) - (PDF)

 

 
horizontal rule