FDA product code DNL: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
DNL is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, second antibody sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 8 510(k) submissions under DNL, from 8 different applicants. The average 510(k) review took 28 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DNL clearance
Top DNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| M Nobird, Inc. | 1 | 1985-07-09 |
| Nuclear Diagnostics, Inc. | 1 | 1985-06-25 |
| Immuno Assay Corp. | 1 | 1981-05-21 |
| E. R. Squibb & Sons, Inc. | 1 | 1981-04-21 |
| American Diagnostic Corp. | 1 | 1980-12-18 |
3 more applicants have DNL clearances. See the full list in Caduvo.
Most recent DNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852343 | M Nobird, Inc. | DIG RADIOIMMUNOASSAY TEST SYSTEM | 1985-07-09 | 36 |
| K852291 | Nuclear Diagnostics, Inc. | TIPSEP DIGOXIN RIA | 1985-06-25 | 27 |
| K811212 | Immuno Assay Corp. | DIGOXIN (RIA) KIT | 1981-05-21 | 17 |
| K810966 | E. R. Squibb & Sons, Inc. | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | 1981-04-21 | 13 |
| K802841 | American Diagnostic Corp. | DIGOXIN RADIOIMMUNOASSAY KIT | 1980-12-18 | 36 |
Recalls for DNL devices
openFDA lists no recalls for product code DNL.
Frequently asked questions
What is FDA product code DNL?
DNL is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, second antibody sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DNL?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DNL?
Across 8 cleared submissions the average was 28 days from receipt to decision (median 22).
Which companies have the most DNL clearances?
M Nobird, Inc. (1); Nuclear Diagnostics, Inc. (1); Immuno Assay Corp. (1); E. R. Squibb & Sons, Inc. (1); American Diagnostic Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DNL
- Run a recall and safety report across every DNL manufacturer
- Watch product code DNL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times