Device product

Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443

Z-1705-2020

March 16, 2020

Class II

Product summary

Firm: Life Technologies Corporation
Event: Event 85203
Status: Terminated
Classification: Class II
Quantity: 66 units
Official record key: device-enforcement:Z-1705-2020

Official wording

Reason: Extended Expiration Date prior to clearance

Code information: Lot Codes: S119_2174739 S119_2108428 P119_2149305 N119_2078114 S218_2069395 V118_1991154 T118_1990946 S118_1988603 P118_1996940 S117_1988306 UDI: (01)10190302006064

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Extended Expiration Date prior to clearance