FDA product code NDZ: Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
NDZ is the FDA product code for assay, nucleic acid amplification, growth identification, mycobacterium tuberculosis. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under NDZ. The average 510(k) review took 305 days (median 305). FDA has posted 1 recall for NDZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis |
| Device class | Class I |
| Regulation | 21 CFR 866.3370 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NDZ clearance
Top NDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton Dickinson Biosciences | 1 | 2001-01-19 |
Most recent NDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000884 | Becton Dickinson Biosciences | BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY | 2001-01-19 | 305 |
Recalls for NDZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-06-11.
Frequently asked questions
What is FDA product code NDZ?
NDZ is the FDA product code for assay, nucleic acid amplification, growth identification, mycobacterium tuberculosis. It is a Class I device, regulated under 21 CFR 866.3370 and reviewed by the Microbiology panel.
What device class is NDZ?
Class I, regulation 21 CFR 866.3370. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDZ?
Across 1 cleared submissions the average was 305 days from receipt to decision (median 305).
Which companies have the most NDZ clearances?
Becton Dickinson Biosciences (1).
Have NDZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-06-11.
Next steps
- Run an FDA pathway report with predicate devices for product code NDZ
- Run a recall and safety report across every NDZ manufacturer
- Watch product code NDZ 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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