NTM · Class II · 21 CFR 866.3210

FDA Product Code NTM: Antigen, Inflammatory Response Marker, Sepsis

An Immunoluminometric Assay Used To Determine The Concentration Of Procalcitonin (pct) In Human Serum And Plasma.

Leading manufacturers include Brahms Aktiengesellschaft and bioMerieux, Inc..

3
Total
3
Cleared
290d
Avg days
2005
Since

FDA 510(k) Cleared Antigen, Inflammatory Response Marker, Sepsis Devices (Product Code NTM)

3 devices
1–3 of 3
Cleared Mar 31, 2008
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
K070310
Brahms Aktiengesellschaft
Microbiology · 424d
Cleared Oct 11, 2007
VIDAS B.R.A.H.M.S. PCT ASSAY
K071146
bioMerieux, Inc.
Microbiology · 170d
Cleared Jan 07, 2005
B-R-A-H-M-S PCT LIA
K040887
Brahms Aktiengesellschaft
Microbiology · 277d

About Product Code NTM - Regulatory Context