Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.

Reason: FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.

Code information: REF 42722 - Lot Numbers 896, 897 & 899

Distribution pattern: US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.