FDA-Device2016-05-04Class II
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Hardy Diagnostics
Hazard
Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.
Sold states
U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
Affected count
3,530 (353 pk/10)
Manufactured in
1430 W McCoy Ln, N/A, Santa Maria, CA, United States
Products
Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1571-2016Don't want to check this manually?
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