Elitechgroup Mdx L L C

FDA Filings

This page includes the latest FDA filings for Elitechgroup Mdx L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003540236
FEI Number3003540236
NameELITechGroup MDX LLC.
Owner & OperatorELITechGroup Inc.
Contact Address370 West 1700 South
Logan UT 84321 US
Official Correspondent
  • Bryce McEuen
  • 1-435-7526011-1487
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address21720 23rd Dr SE, Suite 150
Bothell, WA 98021 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Elitechgroup Mdx LLC
DSQ Alert® Internal Control set IC1 2024-11-01
Elitechgroup Mdx LLC
DSQ Alert Internal Control set IC1 M8007342024-08-06
Elitechgroup Mdx LLC
DSQ Alert HT Probe Mix ASR M8008122024-07-24
Elitechgroup Mdx LLC
DSQ Alert HT Primer Mix ASR m8008112024-07-24
Elitechgroup Mdx LLC
DSQ Alert BKV ASR v3.0 Probe Mix, 48 rxns 2024-05-23
Elitechgroup Mdx LLC
DSQ Alert BK Virus v3.0 Primer Mix 2024-05-23
Elitechgroup Mdx LLC
DSQ Alert™ Parechovirus v2.0 Probe Mix ASR M8007592023-10-13
Elitechgroup Mdx LLC
DSQ Alert™ Parechovirus v2.0 Primer Mix ASR M8007582023-10-13
Elitechgroup Mdx LLC
DSQ Alert HT Candida auris Probe Mix ASR, 192 rxn Final Assembly 2023-09-29
Elitechgroup Mdx LLC
DSQ Alert HT Candida auris Primer Mix ASR, 192 rxn Final Assembly M8007602023-09-29
Elitechgroup Mdx LLC
MGB Alert Enterovirus v.2.0 Probe Mix ASR , 48 rxns M8007092023-09-29
Elitechgroup Mdx LLC
MGB Alert Enterovirus v.2.0 Primer Mix ASR, 48 rxns M8007082023-09-29
Elitechgroup Mdx LLC
DSQ Alert™ MS2-ICB-1 Internal Control Set M8007072023-09-29
Elitechgroup Mdx LLC
MGB Alert HSV2 Probe Mix, 48 rxn ASR, Finished Product M8005882023-09-29
Elitechgroup Mdx LLC
MGB Alert HSV2 Primer Mix, 48 rxn ASR, Finished Product M8005872023-09-29
Elitechgroup Mdx LLC
MGB Alert HSV1 Probe Mix, 48 rxn ASR, Finished Product M8005862023-09-29
Elitechgroup Mdx LLC
MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product M8005852023-09-29
Elitechgroup Mdx LLC
MGB Alert MS2 RNA Internal Control in TE-Yeast RNA M8006982023-03-14
Elitechgroup Mdx LLC
MGB Alert ELITaq Master Mix, 480 rxn M8008102023-02-13
Elitechgroup Mdx LLC
MGB Alert 2X ELITaq Master Mix, 48rxn M8008092023-02-13
Elitechgroup Mdx LLC
MGB Alert® Internal Control set IC1 DSQ 2022-10-10
Elitechgroup Mdx LLC
MGB Alert® BKV ASR v3.0 Probe Mix 2022-10-10
Elitechgroup Mdx LLC
MGB Alert® BKV ASR v3.0 Primer Mix, 48 reactions 2022-10-10
Elitechgroup Mdx LLC
MGB Alert® Internal Control set IC1 DSQ 2022-10-10
Elitechgroup Mdx LLC
MGB Alert® BKV ASR v3.0 Probe Mix 2022-10-10
Elitechgroup Mdx LLC
MGB Alert® BKV ASR v3.0 Primer Mix 2022-10-10
Elitechgroup Mdx LLC
MGB Alert MS2 Internal Control RNA Template (480uL volume) 2022-09-07
Elitechgroup Mdx LLC
MGB Alert MS2 Internal Control DNA Template (250uL volume) 2022-09-07
Elitechgroup Mdx LLC
MGB Alert IC2 Internal Control Template (250uL volume) 2022-09-07
Elitechgroup Mdx LLC
MGB Alert IC2 Internal Control Template 2022-09-07
Elitechgroup Mdx LLC
MGB Alert IC1 Internal Control Template M8007362022-09-07
Elitechgroup Mdx LLC
HSV 1&2 ELITe MGB Assay 2020-10-15
Elitechgroup Mdx LLC
MRSA/SA ELITe MGB 2020-10-15
ELITechGroup MDX LLC. [ELITechGroup Inc.]
Elite InGenius2018-12-06
ELITechGroup MDX LLC. [ELITechGroup Inc.]
ELITe MGB HSV 1&2 Assay2018-12-06
ELITechGroup MDX LLC. [ELITechGroup Inc.]
Elite InGenius2018-12-06
ELITechGroup MDX LLC. [ELITechGroup Inc.]
ELITe MGB HSV 1&2 Assay2018-12-06
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert Internal Control Set IC2-T2017-06-22
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert Internal Control Set IC12017-06-22
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert Internal Control Set IC1-A2017-06-22
ELITechGroup MDX LLC. [ELITechGroup Inc.]
Zika ELITe MGB Kit U.S.2017-04-25
ELITechGroup MDX LLC. [ELITechGroup Inc.]
ELITe MGB Software2013-11-07
ELITechGroup MDX LLC. [ELITechGroup Inc.]
ELITe MGB Software2013-11-07
ELITechGroup MDX LLC. [ELITechGroup Inc.]
ELITe MGB Software2013-11-07
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MRSA/SA ELITe MGB2012-07-20
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert Internal Control Set IC2-B2010-03-01
ELITechGroup MDX LLC. [ELITechGroup Inc.]
INTERNAL CONTROL 2B SET2010-03-01
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert? Positive Controls2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert? Platinum Master Mix2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert? PCR Master Mix2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert? 2X Hot Start Master Mix2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert? C.pneumoniae Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert? C. pneumoniae Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) hMPV Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) hMPV Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) VZV Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) VZV Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HSV Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HSV Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HSV 1,2 Typer Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HSV 1,2 Typer Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HSV 1&2 Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HSV 1&2 Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HHV6 Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HHV6 Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HHV6 2.0 Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) HHV6 2.0 Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) Enterovirus Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) Enterovirus Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) EBV Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) EBV Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) CMV 3.0 Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) CMV 3.0 Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) BK Virus Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) BK Virus Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) B. pertussis/B. parapertussis Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) B. pertussis/B. parapertussis Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) Adenovirus Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert(R) Adenovirus Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert Trichomonas vaginalis Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert Trichomonas vaginalis Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert HSV Typer AS Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert HSV Type 2 Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert HSV Type 2 Primer Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert HSV Type 1 Probe Mix ASR2009-10-12
ELITechGroup MDX LLC. [ELITechGroup Inc.]
MGB Alert HSV Type 1 Primer Mix ASR2009-10-12

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