Identity
- Trade Name
- MGB Alert® Internal Control set IC1 DSQ FDA UDI
- Generic Name
- Nucleic acid amplification primer IVD FDA UDI
- Device Name
- The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB Alert IC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays. FDA UDI
- Model / Reference
- M800734 FDA UDI
- Description
- The MGB Alert Internal Control Set IC1 DSQ contains the MGB Alert IC1 DNA Template, the MGB Alert IC1 v3.0 Primers, and the MGB Alert IC1 DSQ Probe. When used as intended, the Internal Control Set IC1 DSQ will detect systemic variation that may arise during the nucleic acid extraction and amplification processes associated with real-time PCR assays. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661540952333 FDA UDI
- FDA Product Code
- OLD FDA UDI
- GMDN Term
- Nucleic acid amplification primer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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 primer IVD
MGB Alert® Internal Control set IC1 DSQ 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 0a469a51-7f31-4ab9-a748-f0cc704a09da 34 fields · synced May 30, 2026