CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 1 CC908
- Primary DI
- 00817302020458
- Brand
- CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 1 CC908
- Company
- CAROLINA LIQUID CHEMISTRIES CORPORATION
- Model
- CC908
- Catalog number
- CC908
- Device description
- Cal Level 1 (BUN, CA, CREA, CO2, Electrolytes, GLU, PHOS) - CX3 Cal 6x 25 mL
- Published
- 2016-09-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00817302020458 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00817302020458 | 00817302020458 | 817302020458 | 0817302020458 |
GMDN Terms
| Term | Definition |
|---|
| Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb). |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Total Volume | 25 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | After opening, the calibrators are stable for 30 days at room temperature (18 - 25°C) or to their expiration date when stored between 2 - 8° and protected from contamination. |
| Special Storage Condition, Specify | 0 | 0 | Unopened Reagent is stable when stored at 2-8° C until expiration date |
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 962385787
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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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