FDA product code LJB: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
LJB is the FDA product code for enzyme linked immunoabsorbent assay, rubeola igg. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under LJB, from 8 different applicants. The average 510(k) review took 121 days (median 112). FDA has posted 7 recalls for LJB devices, 2 initiated in the last five years.
Definition
The qualitative detection of measles specific IgG antibodies in serum or plasma.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Device class | Class I |
| Regulation | 21 CFR 866.3520 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LJB clearance
Top LJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diamedix Corp. | 2 | 1998-01-28 |
| Baxter Diagnostics, Inc. | 2 | 1992-09-02 |
| Gull Laboratories, Inc. | 2 | 1991-01-03 |
| Inova Diagnostics, Inc. | 1 | 1997-07-22 |
| Virus Reference Laboratory, Inc. | 1 | 1992-03-18 |
3 more applicants have LJB clearances. See the full list in Caduvo.
Most recent LJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K974552 | Diamedix Corp. | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | 1998-01-28 | 55 |
| K971620 | Inova Diagnostics, Inc. | QUANTA LITE RUBEOLA (MEASLES) IGG | 1997-07-22 | 82 |
| K922335 | Baxter Diagnostics, Inc. | BARTELS RUBEOLA IGM EIA | 1992-09-02 | 112 |
| K922330 | Baxter Diagnostics, Inc. | BARTELS RUBEOLA IGG EIA | 1992-09-02 | 112 |
| K910290 | Virus Reference Laboratory, Inc. | VIRATEST-DIA(TM) MEASLES (RUBEOLA) | 1992-03-18 | 421 |
Recalls for LJB devices
7 product recalls in 6 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2025-10-01.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LJB?
LJB is the FDA product code for enzyme linked immunoabsorbent assay, rubeola igg. It is a Class I device, regulated under 21 CFR 866.3520 and reviewed by the Microbiology panel.
What device class is LJB?
Class I, regulation 21 CFR 866.3520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LJB?
Across 11 cleared submissions the average was 121 days from receipt to decision (median 112).
Which companies have the most LJB clearances?
Diamedix Corp. (2); Baxter Diagnostics, Inc. (2); Gull Laboratories, Inc. (2); Inova Diagnostics, Inc. (1); Virus Reference Laboratory, Inc. (1).
Have LJB devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-10-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LJB
- Run a recall and safety report across every LJB manufacturer
- Watch product code LJB 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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