NJWClass II
Control Material, Her-2/neu, Immunohistochemistry
Hematology · 21 CFR 864.1860
Accessory to immunohistochemistry assays for Her2-neu. Control material intended for laboratory use to control Her2-neu immunohistochemistry assays.
MDR events2All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances2All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury1
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code