FDA.reportPublic FDA data

InTray DM-FungID

Primary DI
B08815934
Brand
InTray DM-FungID
Company
BIO-MED DIAGNOSTICS, INC.
Model
1593
Catalog number
21-593-001
Device description
InTray® DM-FungID™ is an enriched dermatophyte medium used to aid in the detection of dermatophytes from clinical specimens with mixed micobiota.
Published
2020-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JSICulture Media, Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B08815932PackageHIBCC5In Commercial Distribution
B08815934PackageHIBCC20In Commercial Distribution
B08815930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple dermatophyte species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of dermatophyte or other fungi isolated by culture from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
605213545
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B088212730010InTray® SAB+PVG21272023-10-05
B08816120Saline Solution (0.85%)161211-612-0012020-09-29
B08816020VTM-C19 Transit Tube160211-602-0012020-10-05
B08815930InTray DM-FungID159321-593-0012020-02-10
B08824830InTray® Mueller Hinton Chocolate Agar248322-483-0012019-10-16
B08824834InTray® Mueller Hinton Chocolate Agar248322-483-0012019-10-16
B08810800InTray™ GC108010-80002016-09-21
B08812630InTray® SAB126321-263-0012018-09-12
B08815030InTray® BHI150321-503-0012018-09-12
B08810804InTray™ GC108010-80002016-09-21
B08812634InTray® SAB126321-263-0012018-09-12
B08815034InTray® BHI150321-503-0012018-09-12
B08820630InTray® DM 206322-063-0002018-09-13
B08814430InTray® TSA144321-443-0012018-09-12
B08814434InTray® TSA144321-443-0012018-09-12
B08810310InPouch® TV103121-031-0012018-08-20
B08810510InPouch® TVC Subculture105121-051-0012018-09-12
B08811030InTray® COLOREX Screen110321-103-0012018-09-13
B08811130InTray® COLOREX Yeast111321-113-0012018-09-13
B08812230InTray® COLOREX Salmonella122321-223-0012018-09-12

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