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IDS-iSYS Intact PTH
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref IS-3200510(k) K103325
Identity
- Trade Name
- IDS-iSYS Intact PTH EUDAMEDFDA UDI
- Generic Name
- Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IDS-iSYS Intact PTH EUDAMED
- Model / Reference
- IS-3200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690264 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690264 EUDAMED
- 510(k) Number
- K103325 FDA UDI
- FDA Product Code
- CEW FDA UDI
- EMDN Code
- W0102060312 PARATHYROID HORMONE INTACT EUDAMED
- GMDN Term
- Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1545 FDA UDI
- Market of Registration
- Belgium 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
Prescription Use
Yes
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
No
FDA UDI
IDS-iSYS Intact PTH by Immunodiagnostic Systems Limited — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103325 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-05060169690264 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- FDA Applicant
- Immunodiagnostic Systems , Ltd.
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (3)
- EUDAMED 8e445961-4ba0-4c48-a5dd-5e3a34748fa6 85 fields · synced Jun 18, 2026
- FDA UDI e011c37b-73b3-4b30-9857-020d3d1ef271 35 fields · synced May 30, 2026
- FDA 510(k) K103325 1 fields · synced May 18, 2026