FDA-Device2016-01-06Class II
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
Biomerieux Inc
Hazard
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Sold states
US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Affected count
24 cartons
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2016Don't want to check this manually?
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