FDA UDI
In Commercial Distribution
🇺🇸 United States
CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL)
DI: 05055273201956
·
Model: CY5005
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL)
- Primary DI
- 05055273201956
- Version / Model
- CY5005
- Catalog Number
- CY5005
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-22
- Public Version
- 1
- Public Version Date
- 2022-09-30
- Public Version Status
- New
- Public Device Record Key
- 2aed495e-7c81-49de-b28b-ac168a78fff8
Device Description
Randox Cytokine high sensitivity controls are intended for use as an assayed quality control in the routine monitoring of accuracy and precision for the analytes listed in this insert. The Randox Cytokine high sensitivity controls are multi-analyte. Each control contains all of the analytes listed overleaf. There are 3 levels of control: low, medium and high; Level 1, 2 and 3 respectively.
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
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53813 | Multiple interleukin/interleukin receptor IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple interleukins and/or interleukin receptors in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273201956 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius