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Parathyroid Hormone Control - Level 1 (pth Control 1)
EUDAMEDFDA UDIClass B (EU MDR)
Ref PTH10110
Identity
- Trade Name
- PARATHYROID HORMONE CONTROL - LEVEL 1 (PTH CONTROL 1) EUDAMEDFDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, control FDA UDI
- Device Name
- PARATHYROID HORMONE CONTROL EUDAMED
- Model / Reference
- PTH10110 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055273215328 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732BPHCLLC090EN EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152002 HORMONE CONTROLS EUDAMED
- GMDN Term
- Parathyroid hormone (PTH) IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Parathyroid Hormone Control - Level 1 (pth Control 1) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50552732BPHCLLC090EN | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 31b3b2ea-af68-445f-a77b-197c68a1656c 61 fields · synced Jul 10, 2026
- FDA UDI f8fa7196-a217-4e32-9458-2b612d7bd1e0 32 fields · synced May 30, 2026