Identity
- Trade Name
- CLUNGENE FDA UDI
- Generic Name
- Human chorionic gonadotropin alpha-subunit IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- Strip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950921302377 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Human chorionic gonadotropin alpha-subunit IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Human chorionic gonadotropin alpha-subunit IVD, kit, chemiluminescent immunoassay
Clungene by Hangzhou Clongene Biotech 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
- Hangzhou Clongene Biotech Co., Ltd.
Sources (1)
- FDA UDI 42e47518-67df-452b-89c1-7023b6afd0f6 32 fields · synced May 30, 2026