FDA-Device2023-04-05Class II
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
Entopsis , Inc.
Hazard
Presence of misleading label statements on the product label.
Sold states
Nationwide and Canada, UK, Portugal, England, Spain, England , Germany, Brazil, Denmark, KOR, South Korea, Colombia, Lithuania
Affected count
397 units
Manufactured in
7600 Nw 69th Ave, N/A, Medley, FL, United States
Products
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2023Don't want to check this manually?
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