Identity
- Trade Name
- Mast Assure Escherichia coli O111 Antiserum FDA UDI
- Generic Name
- Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- M12016 - Escherichia coli Monovalent O Antiserum - Factor O111 - 2ml FDA UDI
- Model / Reference
- M12016 FDA UDI
- Description
- M12016 - Escherichia coli Monovalent O Antiserum - Factor O111 - 2ml FDA UDI
Identifiers
- Catalog Number
- M12016 FDA UDI
- Primary DI / UDI-DI
- 15060392376260 FDA UDI
- FDA Product Code
- GNA FDA UDI
- GMDN Term
- Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3255 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination
Mast Assure Escherichia coli O111 Antiserum by Mast Group , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination.
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
- Mast Group , Ltd.
Sources (1)
- FDA UDI 459433fb-2ac0-497c-8b34-83df85152693 35 fields · synced Jun 6, 2026