FDA product code DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
DHN is the FDA product code for antinuclear antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 110 510(k) submissions under DHN, 1 in the last five years, from 61 different applicants. The average 510(k) review took 67 days (median 36). FDA has posted 7 recalls for DHN devices.
Classification
| Field | Value |
|---|---|
| Device name | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DHN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 266 |
| 2022 | 1 | 654 |
Compare with all 510(k) review times · Search every DHN clearance
Top DHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 14 | 2003-01-17 |
| Immuno Concepts, Inc. | 7 | 1998-12-18 |
| Zeus Scientific, Inc. | 6 | 2022-04-29 |
| Meloy Laboratories, Inc. | 5 | 1985-06-21 |
| Inova Diagnostics, Inc. | 4 | 2015-04-08 |
56 more applicants have DHN clearances. See the full list in Caduvo.
Most recent DHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201956 | Zeus Scientific, Inc. | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | 2022-04-29 | 654 |
| K172745 | Immco Diagnostics, Inc. | ImmuGlo HEp-2 Elite IFA | 2018-06-05 | 266 |
| K153117 | Aesku Systems GmbH&Co.Kg | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | 2016-07-28 | 274 |
| K160265 | Immuno Concepts, N.A. , Ltd. | Image Navigator by Immuno Concepts | 2016-06-17 | 136 |
| K141827 | Euroimmun Us, Inc. | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | 2015-04-17 | 284 |
Recalls for DHN devices
7 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-09-26.
Frequently asked questions
What is FDA product code DHN?
DHN is the FDA product code for antinuclear antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is DHN?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DHN?
Across 110 cleared submissions the average was 67 days from receipt to decision (median 36).
Which companies have the most DHN clearances?
Bio-Rad (14); Immuno Concepts, Inc. (7); Zeus Scientific, Inc. (6); Meloy Laboratories, Inc. (5); Inova Diagnostics, Inc. (4).
Have DHN devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2011-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code DHN
- Run a recall and safety report across every DHN manufacturer
- Watch product code DHN 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.
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