DEVICE: Fungitell® (00862696000203)

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Device Identifier (DI) Information

Fungitell®
FT001
FT001
ASSOCIATES OF CAPE COD, INC.
00862696000203
GS1
2
Assay for (1-3)-β-D-Glucan in Serum
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 18, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 10862696000200 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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