Identity
- Trade Name
- LT Reagent Cards Incubator FDA UDI
- Generic Name
- Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination FDA UDI
- Model / Reference
- LTAFY-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974621793228 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 Reagent Cards Incubator by Zhuhai Longtime Biological Technology Co., Ltd — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Zhuhai Longtime Biological Technology Co., Ltd
Sources (1)
- FDA UDI 3ae45647-315b-45b2-b0a8-bbc7933847e8 33 fields · synced May 30, 2026