FDA.reportPublic FDA data

InTray® COLOREX Screen

Primary DI
B08811030
Brand
InTray® COLOREX Screen
Company
BIO-MED DIAGNOSTICS, INC.
Model
1103
Catalog number
21-103-001
Device description
For rapid isolation and differentiation of urinary tract pathogens. Suitable for direct plating of urine specimens.
Published
2018-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
B08811032PackageHIBCC5In Commercial Distribution
B08811034PackageHIBCC20In Commercial Distribution
B08811030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urinary tract pathogen culture isolate identification IVD, kit, rapidA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple pathogens associated with urinary tract infection, isolated by culture from a clinical specimen, and requiring less incubation time than standard laboratory methods. Organisms may include (but are not limited to) Escherichia coli, Proteus mirabilis, Klebsiella, Staphylococcus aureus, and Candida albicans.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
605213545
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
B08815934InTray 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
B08811130InTray® COLOREX Yeast111321-113-0012018-09-13
B08812230InTray® COLOREX Salmonella122321-223-0012018-09-12

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