JRY
9 FDA 510(k) clearances · Product code
52 daysmedian time to decision
266 days90th percentile
9clearances measured
FDA profile
- Official device name
- Antiserum, Fluorescent, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1
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 |
|---|---|---|
| ATHENA MULTI-LYTE EBV IGG TEST SYSTEM (K042118) | Zeus Scientific, Inc. | 2005-04-29 |
| INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. (K900974) | Stellar Bio Systems, Inc. | 1990-04-16 |
| BION EBV-G (VCA) TEST SYSTEM (K891785) | Bion Ent., Ltd. | 1989-08-31 |
| EBV EARLY ANTIGEN (R+D) (K884829) | Hillcrest Biologicals | 1989-04-12 |
| EBV IGM TEST (K822734) | Gull Laboratories, Inc. | 1982-12-09 |
| EBV-M KIT (K822985) | Litton Bionetics | 1982-12-03 |
| EBV-VCA ANTIBODY ASSAY KIT (K821849) | Biotech Research Laboratories, Inc. | 1982-08-12 |
| EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI (K811262) | Zeus Scientific, Inc. | 1981-05-27 |
| EB-VCA, TEST, ANTIBODY, FLUORESCENT (K780925) | Litton Bionetics | 1978-06-22 |
Track JRY automatically
Every clearance here is in the API, with alerts when new ones post.