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Epredia

RICHARD-ALLAN SCIENTIFIC COMPANY · Model Weigert's Iron Hematoxylin Part A · UDI-DI 00673693089807

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

Description

Gomori’s Trichrome Stain Kit Blue Collagen and its components are used as a special stain kit to distinguish between collagen and muscle fibers. The cytoplasmic stain and the collagen stain are combined into one solution along with phosphotungstic- phosphomolybdic and glacial acetic acids. Muscle cells and cytoplasm favor the red dyes, and this is facilitated by the phosphotungstic acid. Collagen fibers take up the tungstate ion, allowing for the blue dye to selectively bind.

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.