FDA product code NZS: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
NZS is the FDA product code for fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under NZS. The average 510(k) review took 205 days (median 183).
Definition
Indicated as a qualitative nucleic acid hybridization assay intended for identification of candida albicans from blood cultures with yeast.
Classification
| Field | Value |
|---|---|
| Device name | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NZS clearance
Top NZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advandx, Inc. | 3 | 2010-07-15 |
Most recent NZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093024 | Advandx, Inc. | YEAST TRAFFIC LIGHT PNA FISH | 2010-07-15 | 289 |
| K092784 | Advandx, Inc. | C. ALBICANS/C. GLABRATA PNA FISH | 2010-03-12 | 183 |
| K092655 | Advandx, Inc. | C. ALBICANS PNA FISH | 2010-01-19 | 144 |
Recalls for NZS devices
openFDA lists no recalls for product code NZS.
Frequently asked questions
What is FDA product code NZS?
NZS is the FDA product code for fish (fluorescent in situ hybridization) kit, protein nucleic acid, rna, yeast. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is NZS?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NZS?
Across 3 cleared submissions the average was 205 days from receipt to decision (median 183).
Which companies have the most NZS clearances?
Advandx, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code NZS
- Run a recall and safety report across every NZS manufacturer
- Watch product code NZS 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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