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ELITechGroup MDX LLC.

US

Last updated September 17, 2026

Information

Country
US
Address
21720 23rd Dr SE, Suite 150, Bothell, WA, 98021
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3003540236
DUNS Number
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Catalogue (142)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
MGB Alert® Bordetella P/PP Primer Mix ASR - 48 Reactions 800437
FDA UDI
Class IActive
DSQ Alert™ Parechovirus v2.0 Probe Mix ASR M800759
FDA UDI
Class IActive
MGB Alert HSV-2 Probe Mix ASR, 09N45-002 M800588-am
FDA UDI
Class IActive
Zika ELITe MGB® - EUA M800552
FDA UDI
N/AActive
MGB Alert EBV Primer Mix ASR, 09N39-003 800414-am
FDA UDI
Class IActive
MGB Alert Platinum Master Mix, 09N41-005 M800599-am
FDA UDI
Class IActive
MGB Alert® BKV ASR v3.0 Probe Mix M800733
FDA UDI
Class IActive
MGB Alert® HHV8 Probe Mix ASR - 48 Reactions M800598
FDA UDI
Class IActive
MGB Alert Platinum Master Mix-480rxn M800691
FDA UDI
Class IActive
MGB Alert HSV2 Primer Mix, 48 rxn ASR, Finished Product M800587
FDA UDI
Class IActive
MGB Alert® CMV 3.0 Primer Mix ASR - 480 Reaction 800350
FDA UDI
Class IActive
MGB Alert EBV Probe Mix ASR, 09N39-002 800424-am
FDA UDI
Class IActive
DSQ Alert Candida auris Probe Mix ASR 800730
FDA UDI
Class IActive
MGB Alert HHV-6 Probe Mix ASR - 480 rxn 800339
FDA UDI
Class IActive
MGB Alert® BKV Probe Mix ASR-480rxn 800333
FDA UDI
Class IActive
MGB Alert IC1 Internal Control Template M800736
FDA UDI
Class IActive
DSQ Alert™ HT HAV Primer Mix ASR M800815
FDA UDI
Class IActive
MGB Alert® JCV Probe Mix ASR - 48 Reactions M800602
FDA UDI
Class IActive
MGB Alert® VZV Primer Mix ASR - 48 rxn 800418
FDA UDI
Class IActive
MGB Alert Internal Control Set IC1 -480rxn 800360
FDA UDI
Class IActive
MGB Alert® hMPV Probe Mix ASR - 48 Reactions 800307
FDA UDI
Class IActive
MRSA/SA ELITe MGB M800346
FDA UDI
Class IIActive
MGB Alert PCR Master Mix 09N41-004 M800331-am
FDA UDI
Class IActive
MGB Alert® hMPV Primer Mix ASR - 48 Reactions 800306
FDA UDI
Class IActive
MGB Alert HSV-1 Primer Mix ASR, 09N44-003 M800585-am
FDA UDI
Class IActive
MGB Alert® Internal Control Set IC2-B, 48 rxn 800430
FDA UDI
Class IActive
MGB Alert Platinum Master Mix, with water-48rxn M800693
FDA UDI
Class IActive
MGB Alert® EBV Primer Mix ASR - 480 Reactions 800334
FDA UDI
Class IActive
MGB Alert® Adenovirus Probe Mix ASR-48rxn 800498
FDA UDI
Class IActive
MGB Alert® CMV 3.0 Probe Mix ASR - 48 Reaction 800423
FDA UDI
Class IActive
DSQ Alert® HT Norovirus GII Probe Mix ASR M800822
FDA UDI
Class IActive
MGB Alert® Parvovirus Probe Mix ASR - 48 Reactions M800683
FDA UDI
Class IActive
MGB Alert® CMV 3.0 Primer Mix ASR - 48 Reactions 800413
FDA UDI
Class IActive
MGB Alert MS2 Internal Control DNA Template (250uL volume) M800739
FDA UDI
Class IActive
MGB Alert®Internal Control 1C Set, 480 rxn 800361
FDA UDI
Class IActive
MGB Alert HSV 1&2 Typer Primer Mix ASR - 480 rxn 800354
FDA UDI
Class IActive
MGB Alert HSV-1 Probe Mix ASR, 09N44-002 M800586-am
FDA UDI
Class IActive
MGB Alert Enterovirus v.2.0 Probe Mix ASR , 48 rxns M800709
FDA UDI
Class IActive
MGB Alert® Pan Legionella Probe Mix ASR - 48 Reactions M800687
FDA UDI
Class IActive
MGB Alert® EBV Primer Mix ASR - 48 Reactions 800414
FDA UDI
Class IActive
MGB Alert Pneumocystis Primer Mix 48rxn M800573
FDA UDI
Class IActive
MGB Alert® Trichomonas Vaginalis Primer Mix ASR - 48 rxn M800583
FDA UDI
Class IActive
HSV 1&2 ELITe MGB Assay for CE-IVD RTK403ING
FDA UDI
Class IIActive
MGB Alert Internal Control Set IC1 -48rxn 800427
FDA UDI
Class IActive
MGB Alert Platinum Master Mix with water-480rxn M800694
FDA UDI
Class IActive
DSQ Alert™ Parechovirus v2.0 Primer Mix ASR M800758
FDA UDI
Class IActive
DSQ Alert BK Virus v3.0 Primer Mix M800726
FDA UDI
Class IActive
MGB Alert® JCV Primer Mix ASR - 48 Reactions M800601
FDA UDI
Class IActive
MGB Alert HSV Ensemble Primer Mix ASR - 480 rxn 800348
FDA UDI
Class IActive
MGB Alert HHV-6 Probe Mix ASR - 48 rxn 800425
FDA UDI
Class IActive

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