Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
The Radioimmunoassay for Digoxin using iodine-125 with rabbit antibody and coated tube separation is a laboratory test system that measures digoxin in patient serum using a solid-phase coated-tube radioimmunoassay with iodine-125 tracer, used for therapeutic drug monitoring of this narrow therapeutic index cardiac glycoside. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DPO, regulated under 21 CFR 862.3320, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
Research product code DPO in seconds
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Basic Information
- Product Code
- DPO
- 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 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914833 | IMMULITE DIGOXIN | Nov 22, 1991 | Substantially Equivalent | Cirrus Diagnostics, Inc. |
| K905719 | ECLIPSE ICA DIGOXIN | Jan 17, 1991 | Substantially Equivalent | Biotope, Inc. |
| K864449 | DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT | Feb 02, 1987 | Substantially Equivalent | Canadian Bioclinical, Ltd. |
| K833842 | RIA COAT DIGOXIN | Jan 17, 1984 | Substantially Equivalent | Immuno Assay Corp. |
| K832163 | SOPHEIA DIGOXIN EIA KIT | Aug 12, 1983 | Substantially Equivalent | Diagnostic Products Corp. |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | May 04, 1983 | Substantially Equivalent | Immuchem Corp. |
| K811932 | COAT-A-COUNT DIGOXIN RIA | Jul 23, 1981 | Substantially Equivalent | Diagnostic Products Corp. |
| K811776 | KALLESTAD QUANTICOAT 125 DIGOXIN | Jul 10, 1981 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K800205 | RIA PHASE DIGOXIN | Mar 19, 1980 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K791325 | AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM | Aug 16, 1979 | Substantially Equivalent | Micromedic Systems |
| K791355 | VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT | Aug 10, 1979 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K771638 | IGOXIN SOLID PHASE RIA | Oct 07, 1977 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K770365 | RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO | Feb 24, 1977 | Substantially Equivalent | Travenol Laboratories, S.A. |
| K770069 | DIGOXIN CLASP TM RIA KIT | Jan 18, 1977 | Substantially Equivalent | E. R. Squibb & Sons, Inc. |