Identity
- Trade Name
- LT Brucella Antisera Test Reagents FDA UDI
- Generic Name
- Multiple Brucella species total antibody IVD, kit, agglutination FDA UDI
- Model / Reference
- BAT-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974621793235 FDA UDI
- FDA Product Code
- GSM FDA UDI
- GMDN Term
- Multiple Brucella species total antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3085 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
LT Brucella Antisera Test Reagents by Zhuhai Longtime Biological Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Zhuhai Longtime Biological Technology Co., Ltd
Sources (1)
- FDA UDI bf2df005-0a43-4d8f-bc81-e5383cc11996 33 fields · synced May 30, 2026