FDA.reportPublic FDA data

InTray® COLOREX Salmonella

Primary DI
B08812230
Brand
InTray® COLOREX Salmonella
Company
BIO-MED DIAGNOSTICS, INC.
Model
1223
Catalog number
21-223-001
Device description
A chromogenic medium for selective isolation and differentiation of Salmonella species, (e.g., Enterobacteriaceae and other enteric bacteria).The test can be performed with samples composed of mixed populations of bacteria, e.g stool, blood, biological fluids, surface streaks, etc. High sensitivity and specificity of the medium lead to a higher detection rate of Salmonella spp. Selective agents inhibit the growth of gram-positive organisms. Artificial substrates are metabolized by specific microbial enzymes liberating insoluble chromogenic compounds. Salmonella species produce deep pink to mauve colored colonies. Bacteria other than Salmonella spp. produce blue colonies, or are colorless or inhibited.
Published
2018-09-12
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
B08812232PackageHIBCC5In Commercial Distribution
B08812234PackageHIBCC20In Commercial Distribution
B08812230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chromogenic Salmonella species agar culture medium IVDA selective and/or differential agar culture medium containing chromogenic substrates intended to be used for the growth and isolation of Salmonella species from a clinical specimen.

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
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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
B08811030InTray® COLOREX Screen110321-103-0012018-09-13
B08811130InTray® COLOREX Yeast111321-113-0012018-09-13

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