Identity
- Trade Name
- CAL A FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, calibrator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- RX4000 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- RX4000 FDA UDI
- Primary DI / UDI-DI
- 05055273206098 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 A by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 dea32ea0-6cd8-4533-aca7-5d6eb9b9966b 36 fields · synced Jun 8, 2026