Merck, UFC901096D, Amicon® Ultra-15 Centrifugal Filter Unit, registered for IVD use

General description
This Amicon® Ultra 15 mL centrifugal devices is registered for in vitro diagnostic use and intended for concentrating serum, urine, cerebrospinal fluid and other body fluids prior to analysis. It is comonly used in testing urine for Bence Jones protein to diagnose multiple myeloma. This device is also used for assessment of free hormones (i.e. thyroid hormones or testosterone) in serum.

The vertical design and available membrane surface area provide fast sample processing, high sample recovery (typically greater than 90% of dilute starting solution), and the capability for 80-fold concentration. Solute polarization and subsequent fouling of the membrane are minimized by the vertical design, and a physical deadstop in the filter device prevents spinning to dryness and potential sample loss.

The concentrate is collected from the filter device sample reservoir using a pipetter, while the ultrafiltrate is collected in the provided centrifuge tube. The device can be spun in a swinging bucket or fixed angle rotor. With their vertical membrane design and deadstop, Amicon® Ultra 15 mL filters deliver the highest recovery with short spin times.
Application
Ultrafiltration with 10,000 dalton molecular weight cutoff Ultracel® membrane.
Concentration of serum, urine, cerebrospinal fluid and other body fluids prior to analysis.
Purification of macromolecular components found in tissue culture extracts or cell lysates and protein removal prior to HPLS.
Concentration of dilute or pre-purified proteins from column eluents.
Desalting, buffer exchange and protein dialysis.

Features and Benefits
In vitro diagnostic medical device with CE conformity marking.
Ultracel® regenerated cellulose membrane with 10 kDa NMWCO delivers retentate recovery of greater than 90%.
Vertical membrane reduces concentration polarization for ultra-fast spin times (as fast as 10–15 minutes).
Heat-sealed membrane minimizes downstream extractables.
100% integrity tested for reliable performance.
Convenient sample monitoring with translucent housing and volume gradations.
Direct pipettor sample access eliminates processing step to recover concentrate.
High concentration factors of 80–100X.

Legal Information
Amicon is a registered trademark of Merck KGaA, Darmstadt, Germany
ULTRACEL is a registered trademark of Merck KGaA, Darmstadt, Germany