Dimension Vista® LOCI 1 CAL 10445194
by Siemens Healthcare Diagnostics Inc.
Ref 10445194Model DX_LS_LEGACY_00842768016714
Active
CE IVDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD EUDAMED | NumberB-00842768016714 00842768016714 | Date25 Sep 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00842768016714 | Date24 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Dimension Vista LOCI 1 Calibrator EUDAMEDDimension Vista® LOCI 1 CAL GUDID
- Generic Name
- Multiple thyroid marker IVD, calibrator
- Device Name
- DX_LS_LEGACY_00842768016714
- Model / Ref / Catalog
- 10445194, DX_LS_LEGACY_00842768016714, KC660
- Primary DI / UDI-DI
- 00842768016714
- Basic UDI-DI
- B-00842768016714
- 510(k) Number
- FDA Product Code
- JIT
- EMDN Code
- W0102152299 Standards and calibrators - immunochemistry - other
- GMDN Term
- Multiple thyroid marker IVD, calibrator
- Device Class
- Class IVD General EUDAMEDClass II GUDID
- Regulation Number
- 862.1150
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IVD General | Class II |
Other devices from Siemens Healthcare Diagnostics Inc.
Properties
Other properties (17)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No