ELITechGroup MDX LLC.

Registration Details

Registration Name: ELITechGroup MDX LLC.
Registration Number: 3003540236
FEI Number: 3003540236
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 21720 23rd Dr SE, Suite 150
City: Bothell
State: WA
ZIP: 98021
Country: US

Regulatory Submissions

510(k) Number: K083430

Owner / Operator

Firm Name: ELITechGroup Inc.
Operator Number: 1717966
Address: 370 West 1700 South
City: Logan
State: UT
Postal Code: 84321
Country: US
Correspondent: Roberto Ortiz

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Reagents, Specific, Analyte	MVU	Class 1	Pathology	No	2009-10-12
Internal Polymerase Chain Reaction Control, Not Assay Specific	OLD	Class 1	Clinical Chemistry	No	2010-03-01
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples	PGI	Class 2	Microbiology	No	2018-12-06
Real Time Nucleic Acid Amplification System	OOI	Class 2	Clinical Chemistry	No	2018-12-06
Reagents, Zika Virus Nucleic Acid	POA	Class N	Unknown	No	2017-04-25
General Purpose Reagent	PPM	Class 1	Pathology	No	2009-10-12

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. MGB Alert® 2X Hot Start Master Mix MGB Alert® PCR Master Mix MGB Alert® Positive Controls MGB Alert® Platinum Master Mix MGB Alert 2X PCR Master Mix (MGB Alert 2X Hot Start Master Mix/Tfi) MGB Alert One-Step Reverse Transcriptase PCR Master Mix Acid Solution System Solution SYSTEM SOLUTION For Viva Drug Testing Systems System Cleaning Solution Envoy Rinse Solution Envoy 500 Wash Solution Kit Envoy Rinse Solution Bulk Kit MGB Alert ELITaq Master Mix 480-rxn - M800810 MGB Alert ELITaq Master Mix 48-rxn - M800809 Envoy ISE Conditioner Envoy Rinse Solution Kit MGB Alert Internal Control Set IC1 MGB Alert Internal Control Set IC1-A MGB Alert Internal Control Set IC2-T MGB Alert Internal Control Set MS2-M 48 MGB Alert Internal Control Set IC2-BH MGB Alert Internal Control Set IC1-L MGB Alert Internal Control Set MS2-E MGB Alert Internal Control Set IC1-V MGB Alert Internal Control Set IC2-8 MGB Alert Internal Control Set IC2-H MGB Alert Internal Control Set IC2-C MGB Alert Internal Control Set IC1-C MGB Alert Internal Control Set IC2 MGB Alert Internal Control Set IC1 DSQ, 48 reactions MGB Alert Internal Control Sec IC1 DSQ, 480 reactions M800698 - MS2 RNA Internal Control in TE-Yeast RNA M800741 - DSQ Alert Internal Control Set IC2, 48 rxn

Establishment Types

Manufacture Medical Device