FDA.reportPublic FDA data

Fungitell STAT

Primary DI
00862696000227
Brand
Fungitell STAT
Company
ASSOCIATES OF CAPE COD, INC.
Model
1
Published
2020-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191167000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191167000Fungitell STATAssociates of Cape Cod, Inc.2019-07-17NQZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862696000227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862696000227008626960002278626960002270862696000227

GMDN Terms#

Term, Definition table
TermDefinition
1,3-Beta-D-glucan IVD, kit, enzyme spectrophotometryA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076574078
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862696000289BG Analytics Software02020-09-11
00862696000210Fungitell®FT001FT0012018-06-29
00862696000203Fungitell®FT001FT0012016-11-18