Transport Medium, Notified per the Vtm Guidance

Viral Transport Medium, 3ml, order by 100/ box For the collection and transport of specimens to the lab for the recovery/identification of viruses. Refrigerate after inoculation. For long…

Registry build 21.09.26

Viral Transport Medium, 3ml, order by 100/ box For the collection and transport of specimens to the lab for the recovery/identification of viruses. Refrigerate after inoculation. For long term storage after inoculation, freeze at -70C. Do not moisten swab with the media prior to use. Refer to the IFU.

5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (3), Shandong (1), Hunan (1).

Chinese manufacturers registered for FDA product code QMC
Manufacturer City Province Registered as Device types
Citotest Labware Manufacturing Co., Ltd. Haimen Jiangsu Repacker / relabeller 46
Citotest Scientific Co., Ltd. Nanjing Jiangsu Repacker / relabeller 46
Jinan Babio Biotechnology Co., Ltd. Jinan Shandong Manufacturer 25
Jiangsu Rongye Technology Co., Ltd. Yangzhou Jiangsu Manufacturer 16
Changsha Renji Medical Equipment Co., Ltd. Changsha Hunan Manufacturer 15

Record

Regulatory record for Transport Medium, Notified Per The Vtm Guidance
Listed by Hardy Diagnostics, United States
FDA product code QMC
Device type Transport Medium, Notified Per The Vtm Guidance
Device class Class 1
Regulation 21 CFR 866.2390
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-01-25
Record revised 2024-10-04 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 30 °C
Distribution end date 2024-10-03

Catalogue Numbers

Catalogue numbers for Transport Medium, Notified Per The Vtm Guidance
Catalogue number Size Per pack Status
R64BX 100 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Biosci™ Shenzhen Dakewe BIO-Engineering Co., Ltd. 3
Babio Jinan Babio Biotechnology Co., Ltd. 2
SNT Biotech Shenzhen Dakewe BIO-Engineering Co., Ltd. 2

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer