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LT Brucella Antibody Test Kit (Microcolumn Gel Method)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- LT Brucella Antibody Test Kit (Microcolumn Gel Method) FDA UDI
- Generic Name
- Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination FDA UDI
- Model / Reference
- 96 tests /kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974621793396 FDA UDI
- FDA Product Code
- KSY FDA UDI
- GMDN Term
- Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9185 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 Antibody Test Kit (Microcolumn Gel Method) by Zhuhai Longtime Biological Technology Co., Ltd — Class I — FDA UDI — listed in FDA GUDID
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
- Zhuhai Longtime Biological Technology Co., Ltd
Sources (1)
- FDA UDI d82181ef-6127-4fe6-8424-8ed2058bfb8d 33 fields · synced May 30, 2026