Fungitell® FT001

GUDID 00862696000210

Assay for (1-3)-β-D-Glucan in Serum

ASSOCIATES OF CAPE COD, INC.

1,3-Beta-D-glucan IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00862696000210
• NIH Device Record Key: 813dbd86-d461-46bc-b6a1-06789222880a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fungitell®
• Version Model Number: FT001
• Catalog Number: FT001
• Company DUNS: 076574078
• Company Name: ASSOCIATES OF CAPE COD, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862696000203 [Previous]
GS1	00862696000210 [Primary]
GS1	10862696000200 [Unit of Use]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-29

On-Brand Devices [Fungitell®]

• 00862696000210: Assay for (1-3)-β-D-Glucan in Serum
• 00862696000203: Assay for (1-3)-β-D-Glucan in Serum