Identity
- Trade Name
- Mast Assure Antisera FDA UDI
- Generic Name
- Shigella sonnei culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- M10150 - Shigella sonnei Monovalent Antiserum - Phase I - 2ml FDA UDI
- Model / Reference
- M10150 FDA UDI
- Description
- M10150 - Shigella sonnei Monovalent Antiserum - Phase I - 2ml FDA UDI
Identifiers
- Catalog Number
- M10150 FDA UDI
- Primary DI / UDI-DI
- 15060392376406 FDA UDI
- FDA Product Code
- GNB FDA UDI
- GMDN Term
- Shigella sonnei culture isolate antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3660 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
Yes
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: Shigella sonnei culture isolate antigen IVD, kit, agglutination
Mast Assure Antisera by Mast Group , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shigella sonnei culture isolate antigen IVD, kit, agglutination.
- Mast Assure — Mast Group , Ltd. · Class II
- Mast Assure Antisera — Mast Group , Ltd. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Mast Group , Ltd.
Sources (1)
- FDA UDI b6328a0f-4e5c-4672-9a89-ce54c6386f2a 35 fields · synced May 31, 2026