Identity
- Trade Name
- OLO Control Kit FDA UDI
- Generic Name
- Full blood count IVD, control FDA UDI
- Device Name
- An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser. FDA UDI
- Model / Reference
- OCK1 FDA UDI
- Description
- An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B787OCK10 FDA UDI
- FDA Product Code
- JCN FDA UDI
- GMDN Term
- Full blood count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
OLO Control Kit by S.D. Sight Diagnostics Ltd — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- S.D. Sight Diagnostics Ltd
Sources (2)
- FDA UDI 4374b0f8-f627-438f-90ab-9ac8f0801956 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced May 29, 2026