Trypsin

FDA product code IBG · Class I (low risk) · 21 CFR 864.4400 · Pathology

2510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K802493SputasolIBG · Traditional Oxoid U.S.A., Inc.11/12/1980SE
K771955Trypsin 1%IBG · Traditional Flow Laboratories, Inc.11/22/1977SE

Recalls

RecallProductFirmInitiated
Z-3005-2018 Class IISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC)…Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC… Ventana Medical Systems Inc08/02/2018Terminated