Identity
- Trade Name
- MGB Alert 2X ELITaq Master Mix, 48rxn FDA UDI
- Generic Name
- Nucleic acid amplification mastermix kit IVD FDA UDI
- Device Name
- The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product. FDA UDI
- Model / Reference
- M800809 FDA UDI
- Description
- The MGB Alert ELITaq Master Mix is a premixed ready-to-use solution containing necessary components and reaction buffer for efficient amplification of DNA templates by PCR. The solution is supplied at 2X relative to the optimal final concentration in the PCR, and contains 2X reaction buffer, dNTPs, MgCl2, and DNA polymerase with 5’ - 3’ exonuclease activity. PCR grade water is also provided in the product. FDA UDI
Identifiers
- Catalog Number
- M800809 FDA UDI
- Primary DI / UDI-DI
- 03661540952517 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Nucleic acid amplification mastermix kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nucleic acid amplification mastermix kit IVD
MGB Alert 2X ELITaq Master Mix, 48rxn by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ELITechGroup MDX LLC.
Sources (1)
- FDA UDI 44b4697f-375a-4b9a-952d-52c7b375fbf6 35 fields · synced May 30, 2026