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Sight OLO

FDA UDI

Class II (US FDA UDI)

by S.D. Sight Diagnostics Ltd

Identity

Trade Name
Sight OLO FDA UDI
Generic Name
Haematological cell analyser IVD FDA UDI
Device Name
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. FDA UDI
Model / Reference
OLO-U1 FDA UDI
Description
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. FDA UDI

Identifiers

Primary DI / UDI-DI
B787OLOU10 FDA UDI
510(k) Number
K190898 FDA UDI
FDA Product Code
GKZ FDA UDI
GMDN Term
Haematological cell analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Sight OLO by S.D. Sight Diagnostics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
S.D. Sight Diagnostics Ltd

Sources (1)

  • FDA UDI b3165bd1-63b2-4382-b090-d1f9eb242d31 35 fields · synced Jun 8, 2026