FDA-Device2021-04-21Class II

Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE

Krishe Inc
Hazard

Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

Sold states
US: LA, TX, FL, GA
Affected count
1,700,000 units
Manufactured in
8105 Razor Blvd Ste 213, N/A, Plano, TX, United States
Products
Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1420-2021

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