FDA-Device2022-09-28Class II
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
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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