FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sight OLO
DI: B787OLOU10
·
Model: OLO-U1
·
S.D. SIGHT DIAGNOSTICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sight OLO
- Primary DI
- B787OLOU10
- Version / Model
- OLO-U1
- Company Name
- S.D. SIGHT DIAGNOSTICS LTD
- Labeler DUNS
- 534144402
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-09
- Public Version
- 4
- Public Version Date
- 2024-11-14
- Public Version Status
- Update
- Public Device Record Key
- b3165bd1-63b2-4382-b090-d1f9eb242d31
- Distribution End Date
- 2024-09-30
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35476 | Haematological cell analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B787OLOU10 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190898 | 000 |