Fungitell STAT

GUDID 00862696000227

ASSOCIATES OF CAPE COD, INC.

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

• Primary Device ID: 00862696000227
• NIH Device Record Key: e6873e7c-92af-4819-8047-867b9cae807e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fungitell STAT
• Version Model Number: 1
• Company DUNS: 076574078
• Company Name: ASSOCIATES OF CAPE COD, INC.
• Device Count: 1
• 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	00862696000227 [Primary]

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: 2020-09-09
• Device Publish Date: 2020-09-01

Devices Manufactured by ASSOCIATES OF CAPE COD, INC.

• 00862696000289 - BG Analytics Software: 2020-09-21 a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process lab
• 00862696000227 - Fungitell STAT: 2020-09-09
• 00862696000227 - Fungitell STAT: 2020-09-09
• 00862696000210 - Fungitell®: 2018-07-30 Assay for (1-3)-β-D-Glucan in Serum
• 00862696000203 - Fungitell®: 2018-06-29 Assay for (1-3)-β-D-Glucan in Serum