LJB
11 FDA 510(k) clearances · Product code
112 daysmedian time to decision
152 days90th percentile
11clearances measured
FDA profile
- Official device name
- Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3520
- Medical specialty
- Microbiology
- FDA definition
- The qualitative detection of measles specific IgG antibodies in serum or plasma.
- Adverse events (MAUDE)
- 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DIAMEDIX IS-MEASLES IGG TEST SYSTEM (K974552) | Diamedix Corp. | 1998-01-28 |
| QUANTA LITE RUBEOLA (MEASLES) IGG (K971620) | Inova Diagnostics, Inc. | 1997-07-22 |
| BARTELS RUBEOLA IGM EIA (K922335) | Baxter Diagnostics, Inc. | 1992-09-02 |
| BARTELS RUBEOLA IGG EIA (K922330) | Baxter Diagnostics, Inc. | 1992-09-02 |
| VIRATEST-DIA(TM) MEASLES (RUBEOLA) (K910290) | Virus Reference Laboratory, Inc. | 1992-03-18 |
| RUBEOLA IGM ELISA TEST (K904083) | Gull Laboratories, Inc. | 1991-01-03 |
| MEASLES IGG MICROASSAY (K903961) | Diamedix Corp. | 1990-12-28 |
| RUBEOLA IGG ELISA TEST (K904854) | Gull Laboratories, Inc. | 1990-12-04 |
| RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 (K891990) | Clinical Sciences, Inc. | 1989-06-15 |
| VIRGO(TM) MEASLES IGG ELISA (K873925) | Electro-Nucleonics Laboratories, Inc. | 1988-02-24 |
| MEASELISA TEST KIT (K821762) | M.A. Bioproducts | 1982-07-30 |
Track LJB automatically
Every clearance here is in the API, with alerts when new ones post.