FDA Registration
Active
🇺🇸 United States
ELITe MGB Software
Reg #: 3003540236
·
FEI: 3003540236
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
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
Regulatory Submissions
- 510(k) Number
- K132468
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 |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2013-11-07 |
| System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen | NQX | Class 2 | Microbiology | No | 2013-11-07 |
| Clinical Sample Concentrator | JJH | Class 1 | Clinical Chemistry | No | 2013-11-07 |
Proprietary Names
ELITe MGB Software
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility