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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Hematoxylin 1 · UDI-DI 00673693089609

HYJ
10
510(k) clearances
7
Adverse events
1
Recalls
40
Facilities

Description

"Periodic Acid-Schiff Stain Kit is a staining kit used to detect carbohydrates, glycogen, basement membranes, and fungus in tissue sections for the diagnosis of general pathology specimens. Periodic acid oxidizes these various tissue moieties to aldehydes, to which Schiff Reagent bonds in its colorless form. Rinsing with water removes the sulfurous acid and restores the Schiff Reagent to its rose-colored form."

Recalls

DateFirmReason
2017-12-19Ventana Medical Systems IncIncreased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINte

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.