FDA UDI
In Commercial Distribution
🇺🇸 United States
CAL A
DI: 05055273206098
·
Model: RX4000
·
RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CAL A
- Primary DI
- 05055273206098
- Version / Model
- RX4000
- Catalog Number
- RX4000
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 5
- Public Version Date
- 2025-05-12
- Public Version Status
- Update
- Public Device Record Key
- dea32ea0-6cd8-4533-aca7-5d6eb9b9966b
Device Description
The product is intended to be used as a wash solution and single point calibrator. Calibrator A is pumped into the sample port by the Calibrator A pump and then positioned in front of the sensor.
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
- No
- 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 |
|---|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | 862.1150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47868 | Multiple-type clinical chemistry analyte profile IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273206098 | GS1 |
Customer Contacts
- Phone
- +44289445170
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Once opened, Calibrator A is stable for 2 months on board the analyser
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius