Data / Medical devices / United States / ELITechGroup MDX LLC.
ELITechGroup MDX LLC.: FDA-registered device maker in Bothell, WA, United States, 2 510(k) clearances
ELITechGroup MDX LLC. is registered with the FDA (registration 3003540236) in Bothell, WA, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 29, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003540236
- Address
- 21720 23rd Dr SE, Suite 150, Bothell, WA, United States, 98021
- Owner or operator
- ELITechGroup Inc. (1717966)
- Roles
- Manufacturer
- First device listed
- October 12, 2009
- Registered through
- 2026
- Brand names listed
- Acid Solution, ELITe MGB HSV 1&2 Assay, Envoy 500 Wash Solution Kit, Envoy ISE Conditioner, Envoy Rinse Solution, Envoy Rinse Solution Bulk Kit, Envoy Rinse Solution Kit, INTERNAL CONTROL 2B SET and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | PGI | 2 | Manufacturer | accessdata.fda.gov |
| Internal Polymerase Chain Reaction Control, Not Assay Specific | OLD | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Manufacturer | accessdata.fda.gov |
| Reagents, Zika Virus Nucleic Acid | POA | N | Manufacturer | accessdata.fda.gov |
| Real Time Nucleic Acid Amplification System | OOI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2018 | K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | PGI | Substantially Equivalent | Elitechgroup | accessdata.fda.gov |
| January 15, 2009 | K083430 | REAL-TIME PCR INTERNAL CONTROL 2B SET | OLD | Substantially Equivalent | Nanogen, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Reagents, Zika Virus Nucleic Acid
- All makers of Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- All makers of Real Time Nucleic Acid Amplification System
- All makers of General Purpose Reagent
- All makers of Internal Polymerase Chain Reaction Control, Not Assay Specific
- All makers of Reagents, Specific, Analyte
Updated October 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.