Identity
- Trade Name
- CAL 2 FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
- Device Name
- The device is intended for use as a calibrator in clinical chemistry assays. Randox calibration sera are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analyzers. FDA UDI
- Model / Reference
- CAL2350 FDA UDI
- Description
- The device is intended for use as a calibrator in clinical chemistry assays. Randox calibration sera are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays on a wide range of automatic analyzers. FDA UDI
Identifiers
- Catalog Number
- CAL2350 FDA UDI
- Primary DI / UDI-DI
- 05055273200959 FDA UDI
- 510(k) Number
- K053153 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type clinical chemistry analyte profile IVD, calibrator
Cal 2 by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K053153 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 430d17df-e4df-4714-a725-475f1e3b0131 37 fields · synced May 30, 2026