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IDS ACTH II Control Set
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref IS-4530NG510(k) K223867
Identity
- Trade Name
- IDS ACTH II Control Set EUDAMEDFDA UDI
- Generic Name
- Adrenocorticotropic hormone (ACTH) IVD, control FDA UDI
- Device Name
- IDS ACTH II EUDAMED
- Model / Reference
- IS-4530NG EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169696532 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169696457YN EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152008 CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES EUDAMED
- GMDN Term
- Adrenocorticotropic hormone (ACTH) IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
No
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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
IDS ACTH II Control Set by Immunodiagnostic Systems Limited — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223867 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 5060169696457YN | Class B | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (3)
- EUDAMED c520ae69-604b-4018-8057-a8ff908924c9 85 fields · synced Jun 18, 2026
- FDA UDI 9e1f79c6-b10c-43b4-98c4-b3e963712ade 34 fields · synced May 30, 2026
- FDA 510(k) K223867 1 fields · synced May 18, 2026