FDA product code DDX: Plasminogen, Antigen, Antiserum, Control
DDX is the FDA product code for plasminogen, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5715 and reviewed by the Hematology panel. FDA has cleared 10 510(k) submissions under DDX, from 10 different applicants. The average 510(k) review took 75 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Plasminogen, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5715 |
| Review panel | HE — Hematology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DDX clearance
Top DDX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Binding Site, Ltd. | 1 | 1994-09-09 |
| Behring Diagnostics, Inc. | 1 | 1989-01-04 |
| Instrumentation Laboratory CO | 1 | 1986-12-04 |
| Kabivitrum, Inc. | 1 | 1986-02-26 |
| Warner-Lambert Co. | 1 | 1985-05-08 |
5 more applicants have DDX clearances. See the full list in Caduvo.
Most recent DDX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941346 | The Binding Site, Ltd. | PLASMINOGEN RID TEST KIT | 1994-09-09 | 172 |
| K884766 | Behring Diagnostics, Inc. | BERICHROM(R) PLASMINOGEN | 1989-01-04 | 51 |
| K864212 | Instrumentation Laboratory CO | IL TEST 97573-15, PLASMINOGEN ASSAY | 1986-12-04 | 37 |
| K854572 | Kabivitrum, Inc. | COATEST PLASMINOGEN | 1986-02-26 | 104 |
| K850410 | Warner-Lambert Co. | GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY | 1985-05-08 | 93 |
Recalls for DDX devices
openFDA lists no recalls for product code DDX.
Frequently asked questions
What is FDA product code DDX?
DDX is the FDA product code for plasminogen, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5715 and reviewed by the Hematology panel.
What device class is DDX?
Class I, regulation 21 CFR 866.5715. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DDX?
Across 10 cleared submissions the average was 75 days from receipt to decision (median 80).
Which companies have the most DDX clearances?
The Binding Site, Ltd. (1); Behring Diagnostics, Inc. (1); Instrumentation Laboratory CO (1); Kabivitrum, Inc. (1); Warner-Lambert Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DDX
- Run a recall and safety report across every DDX manufacturer
- Watch product code DDX 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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