FDA product code LJZ: Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
LJZ is the FDA product code for enzyme linked immunoabsorbent assay, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel. FDA has cleared 13 510(k) submissions under LJZ, from 8 different applicants. The average 510(k) review took 186 days (median 152). FDA has posted 4 recalls for LJZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3375 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LJZ clearance
Top LJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 3 | 1999-01-11 |
| Genbio | 2 | 1997-05-05 |
| Medical Diagnostic Technologies, Inc. | 2 | 1992-06-29 |
| Diatech Diagnostica , Ltd. | 2 | 1989-12-18 |
| Immunoprobe, Inc. | 1 | 1997-07-14 |
3 more applicants have LJZ clearances. See the full list in Caduvo.
Most recent LJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984153 | Zeus Scientific, Inc. | THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. | 1999-01-11 | 53 |
| K971503 | Zeus Scientific, Inc. | MYCOPLASMA IGM ELISA TEST SYSTEM | 1997-08-20 | 118 |
| K971393 | Immunoprobe, Inc. | MYCOPLASMA IGG ELISA TEST SYSTEM | 1997-07-14 | 96 |
| K970150 | Zeus Scientific, Inc. | MYCOPLASMA IGG ELISA TEST SYSTEM | 1997-06-16 | 152 |
| K963054 | Genbio | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | 1997-05-05 | 272 |
Recalls for LJZ devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-08.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code LJZ?
LJZ is the FDA product code for enzyme linked immunoabsorbent assay, mycoplasma spp.. It is a Class I device, regulated under 21 CFR 866.3375 and reviewed by the Microbiology panel.
What device class is LJZ?
Class I, regulation 21 CFR 866.3375. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJZ?
Across 13 cleared submissions the average was 186 days from receipt to decision (median 152).
Which companies have the most LJZ clearances?
Zeus Scientific, Inc. (3); Genbio (2); Medical Diagnostic Technologies, Inc. (2); Diatech Diagnostica , Ltd. (2); Immunoprobe, Inc. (1).
Have LJZ devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2021-02-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LJZ
- Run a recall and safety report across every LJZ manufacturer
- Watch product code LJZ 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times