Identity
- Trade Name
- Urine BETA CrossLaps® (CTX-I) ELISA EUDAMEDFDA UDI
- Generic Name
- Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Urine BETA CrossLaps® (CTX-I) ELISA EUDAMED
- Model / Reference
- AC-05F1 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690158 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169690158WX EUDAMED
- FDA Product Code
- JMM FDA UDI
- EMDN Code
- W0102060304 CROSS-LINKED C-TELOPEPTIDES EUDAMED
- GMDN Term
- Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1400 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Urine BETA CrossLaps® (CTX-I) ELISA by Immunodiagnostic Systems Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5060169690158WX | 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 750df35e-ea0d-43cd-83d0-933f5b75e521 61 fields · synced Jun 18, 2026
- FDA UDI 53a83019-a845-4cc2-9bd7-b66b446ba4c8 34 fields · synced May 30, 2026