Bio-Rad Cyclosporine by HPLC Test
FDA PMAClass II (US FDA PMA)
by Bio-Rad
Identity
- Trade Name
- BIO-RAD CYCLOSPORINE BY HPLC TEST FDA PMA
- Generic Name
- HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE FDA PMA
Identifiers
- PMA Number
- P880032 FDA PMA
- FDA Product Code
- MGS FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 862.1235 FDA PMA
- Regulation Number
- 862.1235 FDA PMA
- Advisory Committee
- Clinical Chemistry FDA PMA
- FDA Decision
- APRL FDA PMA
This device is a High Performance Liquid Chromatography (HPLC) system for the quantitative analysis of cyclosporine in biological samples, classified under Clinical Chemistry. It functions as an in vitro diagnostic test to measure cyclosporine concentrations, aiding in the monitoring of immunosuppressive therapy in transplant patients.
The Bio-Rad Cyclosporine by HPLC Test is intended for laboratory use only and is supplied as a kit for professional use. It is not sterile and is designed for single-use per manufacturer specifications. The device operates under FDA Premarket Approval (PMA) with PMA number P880032, adhering to regulatory standards for Class II medical devices under 21 CFR 862.1235. Storage and handling follow standard laboratory protocols for HPLC reagents and biological samples.
Frequently asked questions
What is the primary clinical use of the Bio-Rad Cyclosporine by HPLC Test, and why is it important for transplant patients?
The Bio-Rad Cyclosporine by HPLC Test is designed for quantitative analysis of cyclosporine in biological samples within a clinical chemistry lab. It helps monitor immunosuppressive therapy levels in transplant patients by measuring cyclosporine concentrations, ensuring therapeutic dosing to prevent rejection while minimizing toxicity.
Is this test kit sterile, and how should it be handled in a lab setting?
No, the Bio-Rad Cyclosporine by HPLC Test kit is not sterile—it is explicitly labeled for professional use in non-sterile laboratory environments. Since it is intended for single-use, proper aseptic techniques should still be followed when preparing biological samples for analysis, adhering to standard HPLC reagent handling protocols.
What regulatory pathway does this device follow, and how does that affect its use in clinical settings?
This device follows the FDA Premarket Approval (PMA) pathway, with PMA number P880032, and is classified as a Class II medical device under 21 CFR 862.1235. This means it has undergone rigorous review to ensure safety and effectiveness for its intended use in measuring cyclosporine levels, giving clinicians confidence in its reliability for transplant monitoring.
How is the kit supplied, and what storage considerations should labs keep in mind?
The kit is supplied as a professional-use laboratory reagent set for single-use applications, meaning each kit is designed for one analysis cycle. Storage should follow standard laboratory protocols for HPLC reagents and biological samples, ensuring proper temperature, humidity control, and protection from light to maintain reagent integrity and accuracy of results.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P880032 | Class II | Active |
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Manufacturer
- Manufacturer
- Bio-Rad
Sources (1)
- FDA PMA P880032 24 fields · synced Sep 18, 2026