Product code NRP— Clinical Toxicology
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
- Classification name
- Sirolimus Test System
- Device class
- Class 2
- Regulation
- 21 CFR 862.3840
- Advisory panel
- Clinical Toxicology
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code NRP
FDA has cleared devices under product code NRP between 2004 and 2009, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2009
- 2008
- 2007
- 2005
- 2004
Top applicants under product code NRP
Recent clearances under product code NRP
- K083487 — EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
- K081857 — DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
- K070822 — ARCHITECT SIROLIMUS ASSAY
- K042411 — ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
- DEN040008 — CEDIA SIROLIMUS ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.