FDA product code MJZ: Kit, Direct Antigen, Positive Control
MJZ is the FDA product code for kit, direct antigen, positive control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under MJZ, from 3 different applicants. The average 510(k) review took 134 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Kit, Direct Antigen, Positive Control |
| Device class | Class I |
| Regulation | 21 CFR 862.1660 |
| Review panel | MI — Microbiology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MJZ clearance
Top MJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Binax, Inc. | 1 | 2009-09-01 |
| Abbott Diagnostics | 1 | 1997-08-13 |
| Blackhawk Biosystems, Inc. | 1 | 1997-08-12 |
Most recent MJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083744 | Binax, Inc. | BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 | 2009-09-01 | 259 |
| K972182 | Abbott Diagnostics | ABBOTT STREP A CONTROLS | 1997-08-13 | 76 |
| K972129 | Blackhawk Biosystems, Inc. | CHLAMYDIATROL AG | 1997-08-12 | 67 |
Recalls for MJZ devices
openFDA lists no recalls for product code MJZ.
Frequently asked questions
What is FDA product code MJZ?
MJZ is the FDA product code for kit, direct antigen, positive control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel.
What device class is MJZ?
Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MJZ?
Across 3 cleared submissions the average was 134 days from receipt to decision (median 76).
Which companies have the most MJZ clearances?
Binax, Inc. (1); Abbott Diagnostics (1); Blackhawk Biosystems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJZ
- Run a recall and safety report across every MJZ manufacturer
- Watch product code MJZ 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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