FDA.reportPublic FDA data

InPouch® TVC Subculture

Primary DI
B08810510
Brand
InPouch® TVC Subculture
Company
BIO-MED DIAGNOSTICS, INC.
Model
1051
Catalog number
21-051-001
Device description
A highly selective growth medium which maintains viable Trichomonas vaginalis cultures (positive controls) for up to seven (7) days.
Published
2018-09-12
Public version status
Update
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
B08810513PackageHIBCC10In Commercial Distribution
B08810510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective broth culture medium IVDA broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00In the dark, away from direct sunlight
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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