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Brahms GmbH

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Known Names

brahms, b.r.a.h.m.s

Recent Recalls

NumberClassProductDate
Z-1795-2026Class IIB.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental GrowMarch 12, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K171338B R A H M S PCT sensitive KRYPTORMay 31, 2017
DEN150009B.R.A.H.M.S PCT sensitive KRYPTORFebruary 20, 2016