ELITechGroup MDX LLC.

FDA Device Registration & Listing · Bothell, WA, US · Registration 3003540236

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003540236
FEI Number
3003540236
Entity Name
ELITechGroup MDX LLC.
City/State/Country
Bothell, WA, US
Establishment Address
21720 23rd Dr SE, Suite 150, Bothell, WA 98021, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ELITechGroup Inc. (Owner Number: 1717966)
Owner / Operator Contact Address
370 West 1700 South, Logan, UT 84321, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

M800850 - DSQ Alert HT Pneumocystis jirovecii Probe Mix ASR M800849 - DSQ Alert HT Pneumocystis jirovecii Primer Mix ASR MGB Alert HSV Type 1 Primer Mix ASR MGB Alert HSV Type 2 Primer Mix ASR MGB Alert HSV Type 2 Probe Mix ASR MGB Alert Trichomonas vaginalis Probe Mix ASR MGB Alert Trichomonas vaginalis Primer Mix ASR MGB Alert HSV Type 1 Probe Mix ASR MGB Alert® C.pneumoniae Primer Mix ASR MGB Alert® C. pneumoniae Probe Mix ASR MGB Alert® JCV (John Cunningham Virus) Primer Mix ASR MGB Alert® HHV8 9Human Herpes Virus - 8 ) Primer Mix ASR MGB Alert® Legionella Pneumophila Primer Mix ASR MGB Alert® Legionella Pneumophila Probe Mix ASR MGB Alert® Parvovirus Probe Mix ASR MGB Alert® JCV (John Cunningham Virus) Probe Mix ASR MGB Alert(R) B. pertussis/B. parapertussis Primer Mix ASR MGB Alert® HHV8 (Human Herpes Virus - 8 ) Probe Mix ASR MGB Alert® Parvovirus Primer Mix ASR MGB Alert® Pan Legionella Probe Mix ASR MGB Alert(R) HHV6 Probe Mix ASR MGB Alert® Pan Legionella Primer Mix ASR MGB Alert(R) hMPV Primer Mix ASR MGB Alert(R) CMV 3 Primer Mix ASR MGB Alert(R) Adenovirus Primer Mix ASR MGB Alert(R) HSV 1,2 Typer Probe Mix ASR MGB Alert(R) HSV Primer Mix ASR MGB Alert(R) BK Virus Probe Mix ASR MGB Alert(R) HSV 1&2 Primer Mix ASR MGB Alert(R) VZV Primer Mix ASR MGB Alert(R) Adenovirus Probe Mix ASR MGB Alert(R) HSV Probe Mix ASR MGB Alert(R) CMV 3 Probe Mix ASR MGB Alert(R) HHV6 2 Primer Mix ASR MGB Alert(R) BK Virus Primer Mix ASR MGB Alert(R) HHV6 2 Probe Mix ASR MGB Alert(R) Enterovirus Probe Mix ASR MGB Alert(R) HSV 1&2 Probe Mix ASR MGB Alert(R) EBV Primer Mix ASR MGB Alert(R) VZV Probe Mix ASR MGB Alert(R) B. pertussis/B. parapertussis Probe Mix ASR MGB Alert(R) Enterovirus Primer Mix ASR MGB Alert(R) HSV 1,2 Typer Primer Mix ASR MGB Alert(R) EBV Probe Mix ASR MGB Alert(R) HHV6 Primer Mix ASR MGB Alert(R) hMPV Probe Mix ASR MGB Alert BKV ASR v3 Primer Mix, 48 Reactions MGB Alert BKV ASR v3 Primer Mix, 480 reactions MGB Alert BKV ASR v3 Probe Mix, 48 Reactions M800816 - DSQ Alert™ HT HAV Probe Mix ASR MGB Alert BKV ASR v3 Probe Mix, 480 Reactions M800818 - MGB Alert HDV Probe Mix ASR, 48 rxn M800730 - DSQ Alert Candida auris Probe Mix ASR, 48 rxn M800814 - DSQ Alert™ HT JCV Probe Mix ASR M800824 - DSQ Alert HT LPN Probe Mix ASR M800812 - DSQ Alert™ HT HDV Probe Mix ASR M800767 - DSQ Alert HHV-7 Probe Mix ASR M800826 - DSQ Alert HT LGN Probe Mix ASR M800819 - DSQ Alert™ HT Norovirus GI Primer Mix ASR M800729 - DSQ Alert Candida auris Primer Mix ASR, 48 rxn M800820 - DSQ Alert™ HT Norovirus GI Probe Mix ASR M800846 - DSQ Alert Measles Probe Mix ASR M800821 - DSQ Alert™ HT Norovirus GII Primer Mix ASR M800848 - DSQ Alert RNase P Probe Mix ASR M800825 - DSQ Alert HT LGN Primer Mix ASR MGB Alert HSV Typer AS Primer Mix ASR M800823 - DSQ Alert HT LPN Primer Mix ASR M800845 - DSQ Alert Measles Primer Mix ASR M800822 - DSQ Alert™ HT Norovirus GII Probe Mix ASR M800815 - DSQ Alert™ HT HAV Primer Mix ASR M800813 - DSQ Alert™ HT JCV Primer Mix ASR M800817 - MGB Alert HDV Primer Mix ASR, 48 rxn M800811 - DSQ Alert™ HT HDV Primer Mix ASR M800847 - DSQ Alert RNase P Primer Mix ASR M800766 - DSQ Alert HHV-7 Primer Mix ASR MGB Alert Internal Control Set IC2-B INTERNAL CONTROL 2B SET ELITe MGB HSV 1&2 Assay Zika ELITe MGB Kit U.S.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2009-10-12
OLD Internal Polymerase Chain Reaction Control, Not Assay Specific Clinical Chemistry Class 1 862.1660 2010-03-01
PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples Microbiology Class 2 866.3309 2018-12-06
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2018-12-06
POA Reagents, Zika Virus Nucleic Acid Unknown Class N N/A 2017-04-25

Official Correspondent

Roberto Ortiz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ELITechGroup Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3044320359 ELITechGroup Inc., Tucson Tucson, AZ, US
3011461582 ELITechGroup S.p.A. Torino Piedmont, IT
3006091463 ELITechGroup MICROBIO SIGNES Var, FR
1717966 ELITechGroup Inc LOGAN, UT, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003540236. Last updated year: 2026. Please use registration number 3003540236 when referencing this establishment in official correspondence.
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