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MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100 FDA UDI
- Generic Name
- Exogenous DNA/RNA internal control IVD, kit FDA UDI
- Model / Reference
- 800363-100 FDA UDI
Identifiers
- Catalog Number
- 800363-100 FDA UDI
- Primary DI / UDI-DI
- 03661540952265 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
Yes
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-B, 480 rxn QTY-100 by Elitechgroup Inc. — 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 Inc.
Sources (1)
- FDA UDI d07a7b58-1921-423a-a4c1-5304cde21d45 34 fields · synced May 30, 2026