FDA.reportPublic FDA data

ELITechGroup MDX LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035402363003540236ELITechGroup MDX LLC.1Y2026-01-0121720 23rd Dr SE, Suite 150 Bothell WA US 98021

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1089821764419289K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusPGI2018-10-29
1089821536595845K132468MRSA/SA ELITE MGB, ELITE MGB SOFTWARENQX2013-10-17
1089821175636932K112937MRSA/SA ELITE MGBNQX2012-06-01
1089821397365503K083430REAL-TIME PCR INTERNAL CONTROL 2B SETOLD2009-01-15
1089822031134576
1089821743020633
1089821915549129
1089821946864853

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQX22013-10-17
PGI12018-10-29
OLD12009-01-15