Identity
- Trade Name
- Mast Assure FDA UDI
- Generic Name
- Vibrio cholerae antigen (multiple serotype) IVD, antibody FDA UDI
- Device Name
- Vibrio cholerae Monovalent Antiserum - OGAWA - 2ml FDA UDI
- Model / Reference
- M11004 FDA UDI
- Description
- Vibrio cholerae Monovalent Antiserum - OGAWA - 2ml FDA UDI
Identifiers
- Catalog Number
- M11004 FDA UDI
- Primary DI / UDI-DI
- 15060392376529 FDA UDI
- FDA Product Code
- GSQ FDA UDI
- GMDN Term
- Vibrio cholerae antigen (multiple serotype) IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3930 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: Vibrio cholerae antigen (multiple serotype) IVD, antibody
Mast Assure by Mast Group , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vibrio cholerae antigen (multiple serotype) IVD, antibody.
- Mast Assure Antisera — Mast Group , Ltd. · Class II
- Mast Assure — Mast Group , Ltd. · Class II
- 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 45eb93d6-7aee-416e-8fb6-745be735ed07 35 fields · synced May 30, 2026