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Sight OLO CBC Test Kit
EUDAMEDFDA UDIFDA 510(k)Class IVD General (EU MDR)
Ref TK1
Identity
- Trade Name
- Sight OLO CBC Test Kit EUDAMEDOLO CBC Test Kit FDA UDI
- Generic Name
- Full blood count IVD, kit, cell count FDA UDI
- Device Name
- Sight OLO CBC Test Kit EUDAMEDA disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer. FDA UDI
- Model / Reference
- TK1 EUDAMEDFDA UDI
- Description
- A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B787TK10 EUDAMEDFDA UDI
- Basic UDI-DI
- B-B787TK10 EUDAMED
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0103010103 COMPLETE CELL COUNT EUDAMED
- GMDN Term
- Full blood count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- Not 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Sight OLO CBC Test Kit by S.D. Sight Diagnostics Ltd — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190898 | Class IVD General | Active |
| FDA 510(k) | United States | FDA_510K | K211840 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-B787TK10 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- S.D. Sight Diagnostics Ltd
- EUDAMED SRN
- IL-MF-000026216
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (3)
- EUDAMED 463e56b8-cbac-4af1-b58d-382eb8221e47 61 fields · synced Jul 14, 2026
- FDA UDI 29b0382c-198c-41cf-b455-c721404111f0 35 fields · synced May 30, 2026
- FDA 510(k) K190898 1 fields · synced May 18, 2026