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MGB Alert One-Step Reverse Transcriptase PCR Master Mix
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- MGB Alert One-Step Reverse Transcriptase PCR Master Mix FDA UDI
- Generic Name
- Nucleic acid amplification mastermix kit IVD FDA UDI
- Device Name
- The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X master mix containing a thermostable polymerase with exonuclease activity and provided in hot-start format. Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separate tubes. FDA UDI
- Model / Reference
- M800689 FDA UDI
- Description
- The MGB Alert One-Step Reverse Transcriptase PCR Master Mix package includes a 2X master mix containing a thermostable polymerase with exonuclease activity and provided in hot-start format. Included are 100X reverse transcriptase, 50X RNase inhibitor, and RNase-free water in separate tubes. FDA UDI
Identifiers
- Catalog Number
- M800689 FDA UDI
- Primary DI / UDI-DI
- 03661540951756 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 One-Step Reverse Transcriptase PCR Master Mix 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 a2a3fda8-4460-4c2b-8501-d88cb7748731 36 fields · synced May 30, 2026