FDA product code LJY: Enzyme Linked Immunoabsorbent Assay, Mumps Virus
LJY is the FDA product code for enzyme linked immunoabsorbent assay, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under LJY, from 8 different applicants. The average 510(k) review took 248 days (median 156). FDA has posted 7 recalls for LJY devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Mumps Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3380 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LJY clearance
Top LJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Columbia Bioscience, Inc. | 1 | 1999-09-03 |
| Quest Intl., Inc. | 1 | 1998-04-23 |
| Gull Laboratories, Inc. | 1 | 1997-11-04 |
| Zeus Scientific, Inc. | 1 | 1996-07-18 |
| Biowhittaker Molecular Applications, Inc. | 1 | 1994-10-14 |
3 more applicants have LJY clearances. See the full list in Caduvo.
Most recent LJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K991274 | Columbia Bioscience, Inc. | MUMPS IGG ELISA TEST SYSTEM | 1999-09-03 | 143 |
| K980059 | Quest Intl., Inc. | SERAQUEST MUMPS IGG | 1998-04-23 | 106 |
| K971857 | Gull Laboratories, Inc. | MUMPS IGG ELISA TESTY | 1997-11-04 | 168 |
| K961204 | Zeus Scientific, Inc. | MUMPS IGG TEST | 1996-07-18 | 113 |
| K925209 | Biowhittaker Molecular Applications, Inc. | MUMPS STAT | 1994-10-14 | 737 |
Recalls for LJY devices
7 product recalls in 7 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-09-22.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code LJY?
LJY is the FDA product code for enzyme linked immunoabsorbent assay, mumps virus. It is a Class I device, regulated under 21 CFR 866.3380 and reviewed by the Microbiology panel.
What device class is LJY?
Class I, regulation 21 CFR 866.3380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJY?
Across 8 cleared submissions the average was 248 days from receipt to decision (median 156).
Which companies have the most LJY clearances?
Columbia Bioscience, Inc. (1); Quest Intl., Inc. (1); Gull Laboratories, Inc. (1); Zeus Scientific, Inc. (1); Biowhittaker Molecular Applications, Inc. (1).
Have LJY devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2021-09-22.
Next steps
- Run an FDA pathway report with predicate devices for product code LJY
- Run a recall and safety report across every LJY manufacturer
- Watch product code LJY 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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