Identity
- Trade Name
- LHsp-IRMA FDA UDI
- Generic Name
- Luteinizing hormone (LH) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- LHsp-IRMA FDA UDI
- Model / Reference
- KIP1311 FDA UDI
- Description
- LHsp-IRMA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05400569000452 FDA UDI
- FDA Product Code
- CEP FDA UDI
- GMDN Term
- Luteinizing hormone (LH) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1485 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Luteinizing hormone (LH) IVD, kit, radioimmunoassay
LHsp-IRMA by Diasource Immunoassays, S.A. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diasource Immunoassays, S.A.
Sources (1)
- FDA UDI 6851b3c3-75d9-4b28-98cc-1d7cf5eedb55 33 fields · synced Jun 1, 2026