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Asuragen, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
DEN190023AmplideX Fragile X Dx & Carrier Screen KitFebruary 21, 2020
DEN160003Quantidex qPCR BCR-ABL IS KitJuly 22, 2016
K113420RNARETAINMarch 16, 2012