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IDS-iSYS CTX-I (CrossLaps®) Control Set
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref IS-3030
Identity
- Trade Name
- IDS-iSYS CTX-I (CrossLaps®) Control Set EUDAMEDIDS-iSYS CTX-I (Crosslaps) Control Set FDA UDI
- Generic Name
- Collagen type I cross-linked C-telopeptide IVD, control FDA UDI
- Device Name
- IDS-iSYS CTX-I (CrossLaps®) Control Set EUDAMED
- Model / Reference
- IS-3030 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690257 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690257 EUDAMED
- 510(k) Number
- K111650 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
- GMDN Term
- Collagen type I cross-linked C-telopeptide IVD, control FDA UDI
Classification
- Device Class
- Class IVD General 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
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 CTX-I (CrossLaps®) Control Set by Immunodiagnostic Systems Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060169690257 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED b06e05b6-3f78-41fc-a4a2-cb762d51f028 61 fields · synced Jul 21, 2026
- FDA UDI 3af3e7e4-0c6f-45eb-abae-734218db76e1 35 fields · synced May 29, 2026