FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OLO Control Kit
DI: B787OCK10
·
Model: OCK1
·
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
- OLO Control Kit
- Primary DI
- B787OCK10
- Version / Model
- OCK1
- 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
- 2020-05-04
- Public Version
- 2
- Public Version Date
- 2024-11-14
- Public Version Status
- Update
- Public Device Record Key
- 4374b0f8-f627-438f-90ab-9ac8f0801956
- Distribution End Date
- 2024-09-30
Device Description
An in vitro diagnostic control reagent designed to monitor values on the Sight OLO multi-parameter hematology analyser.
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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| JCN | Control, Cell Counter, Normal And Abnormal | Hematology | 864.8625 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55866 | Full blood count IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B787OCK10 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius