FDA Registration
Active
🇺🇸 United States
MGB Alert® 2X Hot Start Master Mix
Reg #: 1717966
·
FEI: 1717966
·
Expires 2025
Products
1
Proprietary Names
17
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELITechGroup Inc
- Registration Number
- 1717966
- FEI Number
- 1717966
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 370 West 1700 South
- City
- LOGAN
- State
- UT
- ZIP
- 84321
- 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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Purpose Reagent | PPM | Class 1 | Pathology | No | 2009-10-12 |
Proprietary Names
MGB Alert® 2X Hot Start Master Mix
MGB Alert® PCR Master Mix
MGB Alert® Positive Controls
MGB Alert® Platinum Master Mix
MGB Alert One-Step Reverse Transcriptase PCR Master Mix
MGB Alert 2X PCR Master Mix (MGB Alert 2X Hot Start Master Mix/Tfi)
System Solution
System Cleaning Solution
Acid Solution
SYSTEM SOLUTION For Viva Drug Testing Systems
MGB Alert ELITaq Master Mix 48-rxn - M800809
MGB Alert ELITaq Master Mix 480-rxn - M800810
Envoy Rinse Solution Bulk Kit
Envoy 500 Wash Solution Kit
Envoy Rinse Solution
Envoy ISE Conditioner
Envoy Rinse Solution Kit
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)