FDA product code JRY: Antiserum, Fluorescent, Epstein-Barr Virus
JRY is the FDA product code for antiserum, fluorescent, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. FDA has cleared 9 510(k) submissions under JRY, from 7 different applicants. The average 510(k) review took 94 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Antiserum, Fluorescent, Epstein-Barr Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3235 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JRY clearance
Top JRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 2 | 2005-04-29 |
| Litton Bionetics | 2 | 1982-12-03 |
| Stellar Bio Systems, Inc. | 1 | 1990-04-16 |
| Bion Ent., Ltd. | 1 | 1989-08-31 |
| Hillcrest Biologicals | 1 | 1989-04-12 |
2 more applicants have JRY clearances. See the full list in Caduvo.
Most recent JRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042118 | Zeus Scientific, Inc. | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | 2005-04-29 | 266 |
| K900974 | Stellar Bio Systems, Inc. | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | 1990-04-16 | 45 |
| K891785 | Bion Ent., Ltd. | BION EBV-G (VCA) TEST SYSTEM | 1989-08-31 | 160 |
| K884829 | Hillcrest Biologicals | EBV EARLY ANTIGEN (R+D) | 1989-04-12 | 145 |
| K822734 | Gull Laboratories, Inc. | EBV IGM TEST | 1982-12-09 | 91 |
Recalls for JRY devices
openFDA lists no recalls for product code JRY.
Frequently asked questions
What is FDA product code JRY?
JRY is the FDA product code for antiserum, fluorescent, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel.
What device class is JRY?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
How long does a 510(k) take for product code JRY?
Across 9 cleared submissions the average was 94 days from receipt to decision (median 52).
Which companies have the most JRY clearances?
Zeus Scientific, Inc. (2); Litton Bionetics (2); Stellar Bio Systems, Inc. (1); Bion Ent., Ltd. (1); Hillcrest Biologicals (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JRY
- Run a recall and safety report across every JRY manufacturer
- Watch product code JRY 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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