Micro Total Analysis Instrument System
Clinical Chemistry · 21 CFR 862.2570
A micro total analysis instrument system is a clinical multiplex instrument intended to measure and sort signals generated by fluorescently-labeled immune complexes from a clinical sample on a microcapillary chip. Signals may be quantified using laser-induced-fluorescence detection using filters on a photodiode or other detector. It may integrate microfluidic chips with discrete zones for clinical sample and assay reagents; capillary electrophoresis; reagent handling system; dedicated instrument control; data acquisition software; raw data storage mechanisms; and other essential hardware components and signal reader unit. It is used with specific assays to comprise an assay test system.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Leica Microsystems, Inc.TerminatedJun 7, 2014
Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
Z-1725-2014 · View FDA record ↗ - Leica Microsystems, Inc.TerminatedJun 7, 2014
Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
Z-1726-2014 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
Fujifilm Healthcare Americas Corporation
Edison, NJ, US
Fujifilm Wako Pure Chemical Corporation Diagnostics Design Office (amagasaki)
Amagasaki-shi Hyogo, JP
Fujifilm Healthcare Manufacturing Corporation Minamiashigara Takematsu Office
MINAMIASHIGARA-SHI Kanagawa, JP
Fujifilm Healthcare Manufacturing Corporation Mie Office
Komono-cho, Mie-gun, JP
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.