NRP · Class II · 21 CFR 862.3840

FDA Product Code NRP: Sirolimus Test System

Sirolimus Test Systems Are Intended For The Quantitative Measurement Of Sirolimus In Whole Blood As An Aid In Management Of Transplant Patients Taking This Sirolimus.

Leading manufacturers include Microgenics Corp., Fujirebio Diagnostics,Inc. and Siemens Healthcare Diagnostics, Inc..

5
Total
4
Cleared
137d
Avg days
2004
Since

FDA 510(k) Cleared Sirolimus Test System Devices (Product Code NRP)

5 devices
1–5 of 5
Cleared Mar 30, 2009
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
K083487
Siemens Healthcare Diagnostics
Toxicology · 125d
Cleared Oct 30, 2008
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
K081857
Siemens Healthcare Diagnostics, Inc.
Toxicology · 121d
Cleared Sep 28, 2007
ARCHITECT SIROLIMUS ASSAY
K070822
Fujirebio Diagnostics,Inc.
Toxicology · 186d
Not Cleared Jul 28, 2004
CEDIA SIROLIMUS ASSAY
DEN040008
Microgenics Corp.
Chemistry · 41d

About Product Code NRP - Regulatory Context