FDA-Device2021-04-21Class II

Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R

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
10,000 units
Manufactured in
8105 Razor Blvd Ste 213, N/A, Plano, TX, United States
Products
Dasky Disposable Sampling Tube, REF VSM04 (Saliva Collection Kit + VTM), 10 pcs, IVD, Sterile R

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1423-2021

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