Cyclosporine Radioimmunoassay
The Cyclosporine Radioimmunoassay is an in vitro diagnostic device that uses a radiolabeled immunoassay method to measure cyclosporine levels in blood, used for therapeutic drug monitoring in transplant patients and other patients receiving cyclosporine immunosuppressive therapy. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LTB, regulated under 21 CFR 862.1235, within the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- LTB
- Device Class
- FDA class 2
- Regulation Number
- 862.1235
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K813523 | ELECTRIC SELF STERILIZATION INOCUL. LOOP | Dec 31, 1981 | Substantially Equivalent | Techhnilab Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.