FDA-Device2022-09-28Class II
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Associates of Cape Cod, Inc.
Hazard
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Sold states
Worldwide distribution - US Nationwide distribution in the state of CA and the countries of Austria, France, Germany, India, Ireland, Italy, Spain, UK.
Affected count
243 kits
Manufactured in
124 Bernard E Saint Jean Drive, N/A, East Falmouth, MA, United States
Products
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2022Don't want to check this manually?
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