Fungitell® - Assay for (1-3)-β-D-Glucan in Serum - ASSOCIATES OF CAPE COD, INC.

Duns Number:076574078

Device Description: Assay for (1-3)-β-D-Glucan in Serum

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More Product Details

Catalog Number

FT001

Brand Name

Fungitell®

Version/Model Number

FT001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2018

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

a22e214d-2d3a-4a85-903f-b8d11e566d7f

Public Version Date

June 29, 2018

Public Version Number

4

DI Record Publish Date

November 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASSOCIATES OF CAPE COD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1