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VTM-C19 Transit Tube

FDA UDI

Class I (US FDA UDI)

by Biomed Diagnostics, Inc.

Identity

Trade Name
VTM-C19 Transit Tube FDA UDI
Generic Name
Viral transport medium IVD FDA UDI
Device Name
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. FDA UDI
Model / Reference
1602 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
11-602-001 FDA UDI
Primary DI / UDI-DI
B08816020 FDA UDI
FDA Product Code
JSM FDA UDI
GMDN Term
Viral transport medium IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2390 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Viral transport medium IVD

VTM-C19 Transit Tube by Biomed Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Viral transport medium IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomed Diagnostics, Inc.

Sources (1)

  • FDA UDI 452cd8b3-3fdc-4817-b104-94bc9151f6e8 35 fields · synced May 31, 2026