Respiratory Virus Plus (RV+) Extraction Tray 20-009-020

• • Terminated Z-2684-2014 FDA Class II ·initiated 10 Oct 2013

  Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.

Trade Name

Respiratory Virus Plus (RV+) Extraction Tray

Generic Name

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Model / Reference

20-009-020

Primary DI / UDI-DI

00857573006232

510(k) Number

K103209 ↗

FDA Product Code

OCC

GMDN Term

Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Device Class

Class II

Regulation Number

866.3980

Commercial Distribution

Not in Commercial Distribution

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