FDA product code LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
LFZ is the FDA product code for enzyme linked immunoabsorbent assay, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel. FDA has cleared 58 510(k) submissions under LFZ, 2 in the last five years, from 30 different applicants. The average 510(k) review took 198 days (median 172). FDA has posted 9 recalls for LFZ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Device class | Class II |
| Regulation | 21 CFR 866.3175 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for LFZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 81 |
| 2018 | 1 | 84 |
| 2022 | 2 | 203 |
Compare with all 510(k) review times · Search every LFZ clearance
Top LFZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 6 | 2022-10-27 |
| Zeus Scientific, Inc. | 5 | 1999-01-11 |
| Behring Diagnostics, Inc. | 5 | 1996-10-09 |
| Roche Diagnostics | 4 | 2022-10-12 |
| Gull Laboratories, Inc. | 4 | 1992-02-14 |
25 more applicants have LFZ clearances. See the full list in Caduvo.
Most recent LFZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K220949 | Abbott Laboratories | Architect CMV IgG | 2022-10-27 | 209 |
| K220911 | Roche Diagnostics | Elecsys CMV IgG | 2022-10-12 | 197 |
| K181213 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | 2018-07-30 | 84 |
| K163569 | Roche Diagnostics | Elecsys CMV IgM | 2017-03-17 | 88 |
| K162969 | DiaSorin, Inc. | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | 2017-01-06 | 74 |
Recalls for LFZ devices
9 product recalls in 9 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LFZ?
LFZ is the FDA product code for enzyme linked immunoabsorbent assay, cytomegalovirus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel.
What device class is LFZ?
Class II, regulation 21 CFR 866.3175. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFZ?
Across 58 cleared submissions the average was 198 days from receipt to decision (median 172).
Which companies have the most LFZ clearances?
Abbott Laboratories (6); Zeus Scientific, Inc. (5); Behring Diagnostics, Inc. (5); Roche Diagnostics (4); Gull Laboratories, Inc. (4).
Have LFZ devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LFZ
- Run a recall and safety report across every LFZ manufacturer
- Watch product code LFZ 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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