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IDS Beta CrossLaps® (CTX-I) Control Set
EUDAMEDFDA UDIClass B (EU MDR)
Ref IS-3030NModel IS-3000N
Identity
- Trade Name
- IDS Beta CrossLaps® (CTX-I) Control Set EUDAMEDFDA UDI
- Generic Name
- Procollagen type I C-terminal propeptide (PICP) IVD, control FDA UDI
- Device Name
- IDS Beta CrossLaps® (CTX-I) EUDAMED
- Model / Reference
- IS-3000N EUDAMEDIS-3030N EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169696051 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169695986ZF EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Procollagen type I C-terminal propeptide (PICP) 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
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
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 Beta CrossLaps® (CTX-I) Control Set by Immunodiagnostic Systems 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 | 5060169695986ZF | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | 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 16b512be-b9d1-4053-a837-4b8e754d874b 61 fields · synced Jul 10, 2026
- FDA UDI faaf954f-018e-4e2a-9554-518816081c11 34 fields · synced May 30, 2026