Identity
- Trade Name
- LT Rh Phenotype Card FDA UDI
- Generic Name
- Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination FDA UDI
- Model / Reference
- RPC-8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974621793174 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
- 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
Category: Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination
LT Rh Phenotype Card by Zhuhai Longtime Biological Technology Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rhesus (Rh) phenotype (CcDEe) multiple blood grouping IVD, kit, agglutination.
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- DG Gel 8 Anti-e — DIAGNOSTIC GRIFOLS SA
- DG Gel 8 Anti-D — DIAGNOSTIC GRIFOLS SA
- MTS — MICRO TYPING SYSTEMS, INC
- DG Gel 8 Rh Pheno — DIAGNOSTIC GRIFOLS SA
- LT Rh Phenotype Card — Zhuhai Longtime Biological Technology Co., Ltd · Class I
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 b2c5c404-17a5-453f-80aa-1df14598934f 32 fields · synced May 31, 2026