JRY — Antiserum, Fluorescent, Epstein-Barr Virus Class I
FDA product code JRY covers "Antiserum, Fluorescent, Epstein-Barr Virus", a Class I medical device regulated under 21 CFR 866.3235. Submissions are reviewed by the Microbiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JRY
- Device Class
- Class I
- Regulation Number
- 866.3235
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042118 | zeus scientific | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | April 29, 2005 |
| K900974 | stellar bio systems | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | April 16, 1990 |
| K891785 | bion ent | BION EBV-G (VCA) TEST SYSTEM | August 31, 1989 |
| K884829 | hillcrest biologicals | EBV EARLY ANTIGEN (R+D) | April 12, 1989 |
| K822734 | gull laboratories | EBV IGM TEST | December 9, 1982 |
| K822985 | litton bionetics | EBV-M KIT | December 3, 1982 |
| K821849 | biotech research laboratories | EBV-VCA ANTIBODY ASSAY KIT | August 12, 1982 |
| K811262 | zeus scientific | EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI | May 27, 1981 |
| K780925 | litton bionetics | EB-VCA, TEST, ANTIBODY, FLUORESCENT | June 22, 1978 |