CLINICAL CHEMISTRY LINEARITY VERIFIERS (For Roche Systems)
- Primary DI
- 05055273216684
- Brand
- CLINICAL CHEMISTRY LINEARITY VERIFIERS (For Roche Systems)
- Company
- RANDOX LABORATORIES LIMITED
- Model
- LV10390
- Catalog number
- LV10390
- Device description
- Clinical Chemistry Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Albumin, BUN, Calcium, Total Cholesterol, Creatinine, Glucose, Lactate, Lithium, Magnesium, Phosphate, Total Protein, Triglycerides, Uric acid, Iron, Sodium, Potassium and Chloride assays.
- Published
- 2020-07-15
- 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 |
|---|
| 05055273216684 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 05055273216684 | 05055273216684 | 5055273216684 |
GMDN Terms
| Term | Definition |
|---|
| Multiple clinical chemistry analyte 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 clinical chemistry analytes, and which together may create a full general biochemistry profile. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | -70 Degrees Celsius | -20 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
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