S.D. SIGHT DIAGNOSTICS LTD

Address:23 Menachem Begin Rd.,Tel-Aviv Tel Aviv,IL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Counter, Differential Cell (GKZ) (2) Control, Cell Counter, Normal And Abnormal (JCN) (1)

Premarket Exempt

No Yes

Clear

OLO Control Kit - B787OCK10 Catalog Number :

Device Description : An in vitro diagnostic control reagent designed to monitor values on the Sight O An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser.

Device Class : 2

Duns Number: 534144402

Premarket Exempt : Yes

Product Code : JCN

Prescription Use : Yes

Device Count : 1

Sight OLO - B787OLOU10 Catalog Number :

Device Description : The Sight OLO device is a computer vision based platform for blood analysis. The 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.

Device Class : 2

Duns Number: 534144402

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

OLO CBC Test Kit - B787TK10 Catalog Number :

Device Description : A disposable cartridge and sample preparation tools for use with the Sight OLO C A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

Device Class :

Duns Number: 534144402

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

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