Antiserum, Fluorescent, Epstein-Barr Virus
The Antiserum, Fluorescent, Epstein-Barr Virus is a microbiology diagnostic reagent consisting of fluorescently labeled antibodies against Epstein-Barr virus (EBV) antigens, used in indirect or direct immunofluorescence assays to detect EBV-infected cells or to confirm EBV serology in the diagnosis of infectious mononucleosis and EBV-associated conditions. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JRY and is regulated under 21 CFR 866.3235, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JRY
- Device Class
- FDA class 1
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K042118 | ATHENA MULTI-LYTE EBV IGG TEST SYSTEM | Apr 29, 2005 | Substantially Equivalent | Zeus Scientific, Inc. |
| K900974 | INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. | Apr 16, 1990 | Substantially Equivalent | Stellar Bio Systems, Inc. |
| K891785 | BION EBV-G (VCA) TEST SYSTEM | Aug 31, 1989 | Substantially Equivalent | Bion Ent., Ltd. |
| K884829 | EBV EARLY ANTIGEN (R+D) | Apr 12, 1989 | Substantially Equivalent | Hillcrest Biologicals |
| K822734 | EBV IGM TEST | Dec 09, 1982 | Substantially Equivalent | Gull Laboratories, Inc. |
| K822985 | EBV-M KIT | Dec 03, 1982 | Substantially Equivalent | Litton Bionetics |
| K821849 | EBV-VCA ANTIBODY ASSAY KIT | Aug 12, 1982 | Substantially Equivalent | Biotech Research Laboratories, Inc. |
| K811262 | EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI | May 27, 1981 | Substantially Equivalent | Zeus Scientific, Inc. |
| K780925 | EB-VCA, TEST, ANTIBODY, FLUORESCENT | Jun 22, 1978 | Substantially Equivalent | Litton Bionetics |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.