M800814 - DSQ Alert HT JCV Probe Mix ASR

Registration Details

Registration Name: ELITechGroup MDX LLC.
Registration Number: 3003540236
FEI Number: 3003540236
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 21720 23rd Dr SE, Suite 150
City: Bothell
State: WA
ZIP: 98021
Country: US

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

Proprietary Names

M800814 - DSQ Alert HT JCV Probe Mix ASR M800826 - DSQ Alert HT LGN Probe Mix ASR MGB Alert HSV Type 2 Probe Mix ASR MGB Alert HSV Type 2 Primer 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 HSV Type 1 Primer Mix ASR MGB Alert® C. pneumoniae Probe Mix ASR MGB Alert® C.pneumoniae Primer Mix ASR MGB Alert® JCV (John Cunningham Virus) Probe Mix ASR MGB Alert® HHV8 9Human Herpes Virus - 8 ) Primer Mix ASR MGB Alert® Legionella Pneumophila Probe Mix ASR MGB Alert(R) Adenovirus Probe Mix ASR MGB Alert(R) hMPV Primer Mix ASR MGB Alert(R) Enterovirus Primer Mix ASR MGB Alert® Pan Legionella Primer Mix ASR MGB Alert® JCV (John Cunningham Virus) Primer Mix ASR MGB Alert® HHV8 (Human Herpes Virus - 8 ) Probe Mix ASR MGB Alert(R) CMV 3 Primer Mix ASR MGB Alert® Parvovirus Probe Mix ASR MGB Alert® Parvovirus Primer Mix ASR MGB Alert® Legionella Pneumophila Primer Mix ASR MGB Alert(R) B. pertussis/B. parapertussis Primer Mix ASR MGB Alert® Pan Legionella Probe Mix ASR MGB Alert(R) HHV6 Primer Mix ASR MGB Alert(R) CMV 3 Probe Mix ASR MGB Alert(R) HHV6 Probe Mix ASR MGB Alert(R) HHV6 2 Probe Mix ASR MGB Alert(R) EBV Probe Mix ASR MGB Alert(R) HSV 1,2 Typer Probe Mix ASR MGB Alert(R) Adenovirus Primer Mix ASR MGB Alert(R) BK Virus Probe Mix ASR MGB Alert(R) HSV Probe Mix ASR MGB Alert(R) HHV6 2 Primer Mix ASR MGB Alert(R) VZV Probe Mix ASR MGB Alert(R) HSV 1,2 Typer Primer Mix ASR MGB Alert(R) B. pertussis/B. parapertussis Probe Mix ASR MGB Alert(R) hMPV Probe Mix ASR MGB Alert(R) HSV 1&2 Primer Mix ASR MGB Alert(R) VZV Primer Mix ASR MGB Alert(R) BK Virus Primer Mix ASR MGB Alert(R) HSV Primer 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 M800730 - DSQ Alert Candida auris Probe Mix ASR, 48 rxn MGB Alert BKV ASR v3 Primer Mix, 48 Reactions M800729 - DSQ Alert Candida auris Primer Mix ASR, 48 rxn MGB Alert BKV ASR v3 Probe Mix, 48 Reactions MGB Alert BKV ASR v3 Probe Mix, 480 Reactions MGB Alert HSV Typer AS Primer Mix ASR MGB Alert BKV ASR v3 Primer Mix, 480 reactions M800821 - DSQ Alert HT Norovirus GII Primer Mix ASR M800817 - MGB Alert HDV Primer Mix ASR, 48 rxn M800766 - DSQ Alert HHV-7 Primer Mix ASR M800824 - DSQ Alert HT LPN Probe Mix ASR M800825 - DSQ Alert HT LGN Primer Mix ASR M800816 - DSQ Alert HT HAV Probe Mix ASR M800823 - DSQ Alert HT LPN Primer Mix ASR M800767 - DSQ Alert HHV-7 Probe Mix ASR M800811 - DSQ Alert HT HDV Primer Mix ASR M800815 - DSQ Alert HT HAV Primer Mix ASR M800819 - DSQ Alert HT Norovirus GI Primer Mix ASR M800812 - DSQ Alert HT HDV Probe Mix ASR M800820 - DSQ Alert HT Norovirus GI Probe Mix ASR M800813 - DSQ Alert HT JCV Primer Mix ASR M800818 - MGB Alert HDV Probe Mix ASR, 48 rxn M800822 - DSQ Alert HT Norovirus GII Probe Mix ASR

Establishment Types

Manufacture Medical Device