FDA UDI
In Commercial Distribution
🇺🇸 United States
OLO CBC Test Kit
DI: B787TK10
·
Model: TK1
·
S.D. SIGHT DIAGNOSTICS LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OLO CBC Test Kit
- Primary DI
- B787TK10
- Version / Model
- TK1
- Company Name
- S.D. SIGHT DIAGNOSTICS LTD
- Labeler DUNS
- 534144402
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-09
- Public Version
- 2
- Public Version Date
- 2022-01-27
- Public Version Status
- Update
- Public Device Record Key
- 29b0382c-198c-41cf-b455-c721404111f0
Device Description
A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 55854 | Full blood count IVD, kit, cell count | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B787TK10 | HIBCC | ||||
| Package | B787TK11 | HIBCC | 25 | In Commercial Distribution | ||
| Package | B787TK12 | HIBCC | Case | 8 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 26 Degrees Celsius