Identity
- Trade Name
- MGB Alert Internal Control Set IC2-BH 48 rxn FDA UDI
- Generic Name
- Exogenous DNA/RNA internal control IVD, kit FDA UDI
- Device Name
- The MGB Alert Internal Control Set IC2-BH consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-BH can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. FDA UDI
- Model / Reference
- M800574 FDA UDI
- Description
- The MGB Alert Internal Control Set IC2-BH consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2-BH can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes. FDA UDI
Identifiers
- Catalog Number
- M800574 FDA UDI
- Primary DI / UDI-DI
- 03661540950032 FDA UDI
- FDA Product Code
- OLD FDA UDI
- GMDN Term
- Exogenous DNA/RNA internal control IVD, kit 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: Exogenous DNA/RNA internal control IVD, kit
MGB Alert Internal Control Set IC2-BH 48 rxn by ELITechGroup MDX LLC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Panther Fusion® — Hologic, Inc. · Class I
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 a2242f0f-d582-4cd5-b858-c9d0a98ef0a7 36 fields · synced Jun 1, 2026