Home » FDA POSTS INFORMATION ON RECENTLY APPROVED DIAGNOSTIC PRODUCTS
FDA POSTS INFORMATION ON RECENTLY APPROVED DIAGNOSTIC PRODUCTS
August 31, 2006
The FDA Aug. 30 posted information on two recently approved diagnostic products.
The Monolisa anti-HBs enzyme immunoassay and accompanying anti-HBs calibrator kit, manufactured by Bio-Rad Laboratories, were approved Aug. 25.
The products are used to detect antibodies associated with hepatitis B virus (HBV) infection to determine if a patient has been infected with HBV or is immune to HBV infection, the FDA said.
The approval letter for the products can be viewed at www.fda.gov/cdrh/pdf5/p050048a.pdf (http://www.fda.gov/cdrh/pdf5/p050048a.pdf).
KEYWORDS FDAnews Device Daily Bulletin
Upcoming Events
-
21Oct