Identity
- Trade Name
- Shigella Antisera Set 2 FDA UDI
- Generic Name
- Multiple Shigella species culture isolate antigen IVD, kit, agglutination FDA UDI
- Device Name
- Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for serotyping Shigella, dysenteriae, Shigella flexneri, Shigella boydii and Shigella sonnei strains FDA UDI
- Model / Reference
- M10105 FDA UDI
- Description
- Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for serotyping Shigella, dysenteriae, Shigella flexneri, Shigella boydii and Shigella sonnei strains FDA UDI
Identifiers
- Catalog Number
- M10105 FDA UDI
- Primary DI / UDI-DI
- 15060392378035 FDA UDI
- FDA Product Code
- GNB FDA UDI
- GMDN Term
- Multiple Shigella species 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
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: Multiple Shigella species culture isolate antigen IVD, kit, agglutination
Shigella Antisera Set 2 by Mast Group , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mast Assure Antisera — Mast Group , Ltd. · Class II
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Mast Group , Ltd.
Sources (1)
- FDA UDI 16e68aea-9f07-475c-a276-01e56de79c14 35 fields · synced May 30, 2026