CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL)
- Primary DI
- 05055273201956
- Brand
- CYTOKINE HIGH SENSITIVITY CONTROLS (CTK HS CONTROL)
- Company
- RANDOX LABORATORIES LIMITED
- Model
- CY5005
- Catalog number
- CY5005
- 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.
- Published
- 2022-09-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 05055273201956 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05055273201956 | 05055273201956 | 5055273201956 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +442894451070 | technical.services@randox.com |
Regulatory Flags
- DUNS number
- 227530649
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 05055273218985 | ConcizuTrace™ ELISA | CZM10591 | CZM10591 | 2025-05-30 |
| 05055273210101 | Liquid Immunoassay Control – Level 1 (IA CONTROL 1) | LIA5142 | LIA5142 | 2025-03-24 |
| 05055273210118 | LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) | LIA5143 | LIA5143 | 2025-03-24 |
| 05055273210125 | LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) | LIA5144 | LIA5144 | 2025-03-24 |
| 05055273219814 | PTH CONTROL LEVEL 1 (PTH CONTROL 1) | PTH10608 | PTH10608 | 2025-03-24 |
| 05055273219821 | PTH CONTROL LEVEL 2 (PTH CONTROL 2) | PTH10609 | PTH10609 | 2025-03-24 |
| 05055273219838 | PTH CONTROL LEVEL 3 (PTH CONTROL 3) | PTH10610 | PTH10610 | 2025-03-24 |
| 05055273219043 | LIQUID CARDIAC CONTROL 1 | CQ10534 | CQ10534 | 2025-03-21 |
| 05055273219050 | LIQUID CARDIAC CONTROL 2 | CQ10535 | CQ10535 | 2025-03-21 |
| 05055273219067 | LIQUID CARDIAC CONTROL 3 | CQ10536 | CQ10536 | 2025-03-21 |
| 05055273219128 | LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1) | CQ10616 | CQ10616 | 2025-03-21 |
| 05055273219135 | LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2) | CQ10617 | CQ10617 | 2025-03-21 |
| 05055273219142 | LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3) | CQ10618 | CQ10618 | 2025-03-21 |
| 05055273219159 | Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) | LAL10565 | LAL10565 | 2025-03-21 |
| 05055273219166 | Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10566 | | 2025-03-21 |
| 05055273219173 | Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) | LAE10567 | LAE10567 | 2025-03-21 |
| 05055273219180 | Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) | LAL10625 | LAL10625 | 2025-03-21 |
| 05055273219197 | Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10626 | LAN10626 | 2025-03-21 |
| 05055273219203 | Assayed Liquid Chemistry Control Level 3 (ASY LIQ CHEM CONTROL 3) | LAE10627 | LAE10627 | 2025-03-21 |
| 05055273220018 | PlaySafe™ | SCK10690 | SCK10690 | 2024-10-01 |
Other Devices Sharing Product Codes
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