FDA.reportPublic FDA data

VTM-C19 Transit Tube

Primary DI
B08816020
Brand
VTM-C19 Transit Tube
Company
BIO-MED DIAGNOSTICS, INC.
Model
1602
Catalog number
11-602-001
Device description
The VTM-C19 Transit Tube contains a viral transport medium (VTM) intended to be inoculated with nasopharyngeal (NP) or oropharyngeal (OP) synthetic fiber swab specimens (Not provided), transported appropriately to the lab and analyzed with validated qRT-PCR assays for the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that causes COVID-19 disease in humans. Manufacturers Note: Under enforcement discretion, we are currently exempt of having 510(k) during emergency and threat of Covid.
Published
2020-10-05
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
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B08816021PackageHIBCC1In Commercial Distribution
B08816026PackageHIBCC50In Commercial Distribution
B08816020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Viral transport medium IVDA vessel containing transport medium intended to be used for the preservation and transport of viral culture isolates from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

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

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B08812634InTray® SAB126321-263-0012018-09-12
B08815034InTray® BHI150321-503-0012018-09-12
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B08811130InTray® COLOREX Yeast111321-113-0012018-09-13
B08812230InTray® COLOREX Salmonella122321-223-0012018-09-12

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