FDA product code DDZ: Albumin, Fitc, Antigen, Antiserum, Control
DDZ is the FDA product code for albumin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5040 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under DDZ, from 4 different applicants. The average 510(k) review took 69 days (median 42). FDA has posted 1 recall for DDZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Albumin, Fitc, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5040 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DDZ clearance
Top DDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Good Biotech Corp. | 1 | 2005-04-21 |
| Pointe Scientific, Inc., | 1 | 2003-04-28 |
| Randox Laboratories, Ltd. | 1 | 2000-10-05 |
| Dako Corp. | 1 | 1983-07-18 |
Most recent DDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050576 | Good Biotech Corp. | MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H | 2005-04-21 | 45 |
| K023860 | Pointe Scientific, Inc., | MICROALBUMIN REAGENT SET AND CALIBRATORS | 2003-04-28 | 159 |
| K002674 | Randox Laboratories, Ltd. | RANDOX MICROALBUMIN | 2000-10-05 | 38 |
| K831902 | Dako Corp. | FLUORESCEIN CONJUGATED IMMUNOGLOBIN- | 1983-07-18 | 34 |
Recalls for DDZ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-01-31.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code DDZ?
DDZ is the FDA product code for albumin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5040 and reviewed by the Immunology panel.
What device class is DDZ?
Class II, regulation 21 CFR 866.5040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DDZ?
Across 4 cleared submissions the average was 69 days from receipt to decision (median 42).
Which companies have the most DDZ clearances?
Good Biotech Corp. (1); Pointe Scientific, Inc., (1); Randox Laboratories, Ltd. (1); Dako Corp. (1).
Have DDZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-01-31.
Next steps
- Run an FDA pathway report with predicate devices for product code DDZ
- Run a recall and safety report across every DDZ manufacturer
- Watch product code DDZ 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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