FDA product code LIQ: Enzyme Linked Immunoabsorbent Assay, Rotavirus
LIQ is the FDA product code for enzyme linked immunoabsorbent assay, rotavirus. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel. FDA has cleared 33 510(k) submissions under LIQ, from 23 different applicants. The average 510(k) review took 162 days (median 124). FDA has posted 2 recalls for LIQ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Device class | Class I |
| Regulation | 21 CFR 866.3405 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LIQ clearance
Top LIQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 3 | 1997-08-20 |
| Orion Diagnostica, Inc. | 3 | 1994-12-14 |
| Biomerieux Vitek, Inc. | 2 | 1997-10-03 |
| Ortho Diagnostic Systems, Inc. | 2 | 1989-01-04 |
| Abbott Laboratories | 2 | 1988-05-06 |
18 more applicants have LIQ clearances. See the full list in Caduvo.
Most recent LIQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990842 | Sa Scientific, Inc. | SAS ROTA TEST | 1999-08-09 | 147 |
| K972895 | Biomerieux Vitek, Inc. | VIDAS ROTAVIRUS (RTV) ASSAY | 1997-10-03 | 59 |
| K971585 | Meridian Diagnostics, Inc. | IMMUNOCARD STAT! ROTAVIRUS | 1997-08-20 | 111 |
| K964424 | Trinity Biotech, Inc. | ROTAVIRUS EIA | 1997-08-08 | 276 |
| K965092 | Biomerieux Vitek, Inc. | VIDAS ROTAVIRUS ASSAY | 1997-05-05 | 137 |
Recalls for LIQ devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2022-01-25.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code LIQ?
LIQ is the FDA product code for enzyme linked immunoabsorbent assay, rotavirus. It is a Class I device, regulated under 21 CFR 866.3405 and reviewed by the Microbiology panel.
What device class is LIQ?
Class I, regulation 21 CFR 866.3405. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LIQ?
Across 33 cleared submissions the average was 162 days from receipt to decision (median 124).
Which companies have the most LIQ clearances?
Meridian Diagnostics, Inc. (3); Orion Diagnostica, Inc. (3); Biomerieux Vitek, Inc. (2); Ortho Diagnostic Systems, Inc. (2); Abbott Laboratories (2).
Have LIQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-01-25.
Next steps
- Run an FDA pathway report with predicate devices for product code LIQ
- Run a recall and safety report across every LIQ manufacturer
- Watch product code LIQ 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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