FDA-Device2016-04-13Class II
NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
Northeast Laboratory Services, Inc.
Hazard
Product marketed without a 510 (k)
Sold states
Nationwide Distribution.
Affected count
11720
Manufactured in
227 China Rd, N/A, Winslow, ME, United States
Products
NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1314-2016Don't want to check this manually?
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