Home GUDID 00862696000210 Fungitell®
Primary DI 00862696000210
Brand Fungitell®
Company ASSOCIATES OF CAPE COD, INC.
Model FT001
Catalog number FT001
Device description Assay for (1-3)-β-D-Glucan in Serum
Published 2018-06-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00862696000203 Previous GS1 0 00862696000210 Primary GS1 0 10862696000200 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00862696000203 00862696000203 862696000203 0862696000203 00862696000210 00862696000210 862696000210 0862696000210 10862696000200 10862696000200
GMDN Terms# Term, Definition table Term Definition 1,3-Beta-D-glucan IVD, kit, enzyme spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of 1,3-beta-D-glucan in a clinical specimen, using an enzyme spectrophotometry method. Its is used to aid in the diagnosis of opportunistic fungal infections in immunocompromised (e.g., HIV/AIDS, cancer, transplant) patients.
Regulatory Flags# DUNS number 076574078 Device count 2 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company#