| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B787OCK10 [Primary] |
| JCN | Control, Cell Counter, Normal And Abnormal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-12 |
| Device Publish Date | 2020-05-04 |
| 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. |