Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
The Radioimmunoassay for Digoxin using iodine-125 with goat antibody and anion exchange resin separation is a laboratory test system that quantifies digoxin in patient serum using an anion-exchange resin-based separation radioimmunoassay format with goat-derived antibodies. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DOA, regulated under 21 CFR 862.3320, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DOA
- Device Class
- FDA class 2
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- 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 |
|---|---|---|---|---|
| K032291 | TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | Aug 24, 2004 | Substantially Equivalent | Linde Medical Sensors AG |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.