OLO Control Kit

GUDID B787OCK10

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

S.D. SIGHT DIAGNOSTICS LTD

Full blood count IVD, control

• Primary Device ID: B787OCK10
• NIH Device Record Key: 4374b0f8-f627-438f-90ab-9ac8f0801956
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OLO Control Kit
• Version Model Number: OCK1
• Company DUNS: 534144402
• Company Name: S.D. SIGHT DIAGNOSTICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B787OCK10 [Primary]

FDA Product Code

• JCN: Control, Cell Counter, Normal And Abnormal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-12
• Device Publish Date: 2020-05-04

Devices Manufactured by S.D. SIGHT DIAGNOSTICS LTD

• B787OCK10 - OLO Control Kit: 2020-05-12An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser.
• B787OCK10 - OLO Control Kit: 2020-05-12 An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser.
• B787OLOU10 - Sight OLO: 2020-02-17 The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms fo
• B787TK10 - OLO CBC Test Kit: 2020-02-17 A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.