Device product

Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.

Z-1704-2020

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-1704-2020

Official wording

Reason: Extended Expiration Date prior to clearance

Code information: Lot Codes: S119_2174741 S119_2161574 P119_2149301 N119_2078113 S218_2069394 V118_1991153 T118_1990945 S217_2008383 S118_1988602 P118_1996941 S117_1988305 UDI: (01)10190302006095

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Extended Expiration Date prior to clearance