FDA product code NVQ: Bacteriophage And Controls, B. Anthracis Lysis
NVQ is the FDA product code for bacteriophage and controls, b. anthracis lysis. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under NVQ, from 2 different applicants. The average 510(k) review took 82 days (median 82). FDA has posted 1 recall for NVQ devices, 1 initiated in the last five years.
Definition
A gamma phage lysis assay intended for the identification of bacillus anthracis from non-hemolytic, aerobic gram positive colonies isolated from sheep blood agar. To aid in the laboratory identification of bacillus anthracis culture growth by lysis with a specific bacteriophage.
Classification
| Field | Value |
|---|---|
| Device name | Bacteriophage And Controls, B. Anthracis Lysis |
| Device class | Class II |
| Regulation | 21 CFR 866.3045 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NVQ clearance
Top NVQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| The Surgeon General, Department of the Army | 1 | 2015-04-16 |
| Office of the Surgeon General, U.S. Army | 1 | 2005-08-16 |
Most recent NVQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143592 | The Surgeon General, Department of the Army | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC | 2015-04-16 | 119 |
| K051794 | Office of the Surgeon General, U.S. Army | GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS | 2005-08-16 | 46 |
Recalls for NVQ devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code NVQ?
NVQ is the FDA product code for bacteriophage and controls, b. anthracis lysis. It is a Class II device, regulated under 21 CFR 866.3045 and reviewed by the Microbiology panel.
What device class is NVQ?
Class II, regulation 21 CFR 866.3045. Typical premarket route: 510(k).
How long does a 510(k) take for product code NVQ?
Across 2 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most NVQ clearances?
The Surgeon General, Department of the Army (1); Office of the Surgeon General, U.S. Army (1).
Have NVQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NVQ
- Run a recall and safety report across every NVQ manufacturer
- Watch product code NVQ 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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