Identity
- Trade Name
- Mast Assure Antisera FDA UDI
- Generic Name
- Escherichia coli antigen IVD, kit, agglutination FDA UDI
- Device Name
- M14270 - Escherichia coli Polyvalent O Antiserum - POLY 3 Factors O86, O114, O125, O127, O128 - 2ml FDA UDI
- Model / Reference
- M14270 FDA UDI
- Description
- M14270 - Escherichia coli Polyvalent O Antiserum - POLY 3 Factors O86, O114, O125, O127, O128 - 2ml FDA UDI
Identifiers
- Catalog Number
- M14270 FDA UDI
- Primary DI / UDI-DI
- 15060392376314 FDA UDI
- FDA Product Code
- GNA FDA UDI
- GMDN Term
- Escherichia coli 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
No
FDA UDI
Category: Escherichia coli antigen IVD, kit, agglutination
Mast Assure Antisera by Mast Group , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Escherichia coli antigen IVD, kit, agglutination.
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- Prolex E. coli O111 Latex Reagent — PRO-LAB, INCORPORATED · Class I
- Prolex E. coli O121 Latex Reagent — PRO-LAB, INCORPORATED · Class I
- Wellcolex E.coli O157 — REMEL EUROPE LIMITED · 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
- Mast Group , Ltd.
Sources (1)
- FDA UDI a5e1afb0-5a4d-4e3d-b14c-1e314bc419bd 35 fields · synced May 30, 2026