Radioimmunoassay, Digoxin (125-I)
Radioimmunoassay for digoxin using iodine-125 tracer is a test system used in clinical toxicology to measure serum digoxin levels in patients receiving this cardiac glycoside, which has a narrow therapeutic index requiring careful monitoring to avoid toxicity. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is LCS, regulated under 21 CFR 862.3320, in the Clinical Toxicology specialty. Third-party review is available.
Research product code LCS in seconds
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Basic Information
- Product Code
- LCS
- 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 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K922353 | DIGOXIN COATED TUBE RIA | Aug 24, 1992 | Substantially Equivalent | Monobind |
| K913562 | QMS - DIGOXIN | Aug 30, 1991 | Substantially Equivalent | Seradyn, Inc. |
| K895828 | INNOFLUOR DIGOXIN REAGENT SET | Oct 30, 1989 | Substantially Equivalent | Innotron of Oregon, Inc. |
| K884707 | FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Jan 17, 1989 | Substantially Equivalent | Cyberfluor, Inc. |
| K874748 | IMMPULSE DIGOXIN ASSAY REAGENTS | Feb 19, 1988 | Substantially Equivalent | Sclavo, Inc. |
| K864802 | DART DIGOXIN ASSAY | Feb 12, 1987 | Substantially Equivalent | Coulter Electronics, Inc. |
| K820154 | TDX DIGOXIN | Feb 05, 1982 | Substantially Equivalent | Abbott Laboratories |
| K812749 | ULTRA-DIG | Oct 19, 1981 | Substantially Equivalent | Antibodies, Inc. |
| K803047 | I-125 LABELED DIGOXIN | Dec 22, 1980 | Substantially Equivalent | Pcl-Ria, Inc. |
| K801490 | DIGOXIN EIA KIT | Jul 14, 1980 | Substantially Equivalent | M.A. Bioproducts |
| K801413 | AMERLEX DIGOXIN RIA KIT | Jul 08, 1980 | Substantially Equivalent | Amersham Corp. |
| K801202 | DIGOXIN RADIOIMMUNOASSAY KIT | Jun 20, 1980 | Substantially Equivalent | Technia Diagnostics , Ltd. |
| K800997 | DIGOXIN CLASP RIA KIT | May 08, 1980 | Substantially Equivalent | E. R. Squibb & Sons, Inc. |
| K800773 | DIGOCTK 125 | Apr 24, 1980 | Substantially Equivalent | Sorin Biomedica, Fiat, USA, Inc. |
| K770322 | PHALDEBAS DIGOXIN RIA | Apr 05, 1977 | Substantially Equivalent | Pharmacia, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.