Antiserum, Cf, Epstein-Barr Virus
The Epstein-Barr Virus CF (Complement Fixation) Antiserum is a reference reagent used in complement fixation tests for the serological detection of Epstein-Barr virus (EBV), the causative agent of infectious mononucleosis and a virus associated with several malignancies. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is GNP, regulated under 21 CFR 866.3235 in the Microbiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- GNP
- 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 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020717 | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | Jun 13, 2002 | Substantially Equivalent | Pan Bio Pty. , Ltd. |
| K020707 | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | Jun 13, 2002 | Substantially Equivalent | Pan Bio Pty. , Ltd. |
| K020706 | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | Jun 13, 2002 | Substantially Equivalent | Pan Bio Pty. , Ltd. |
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | Feb 16, 1999 | Substantially Equivalent | Diamedix Corp. |
| K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | Feb 16, 1999 | Substantially Equivalent | Diamedix Corp. |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | Sep 12, 1990 | Substantially Equivalent | Granbio, Inc. |
| K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | Apr 28, 1989 | Substantially Equivalent | Electro-Nucleonics, Inc. |
| K884591 | EBV-VCA ANTIBODY (IGG) | Jan 24, 1989 | Substantially Equivalent | Hillcrest Biologicals |
| K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | Aug 30, 1988 | Substantially Equivalent | Immuno Concepts, Inc. |
| K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | Aug 30, 1988 | Substantially Equivalent | Immuno Concepts, Inc. |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Jun 25, 1987 | Substantially Equivalent | Diagnostic Technology, Inc. |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Feb 02, 1987 | Substantially Equivalent | Granbio, Inc. |
| K861121 | THE GOLDEN QUAD TEST (EBV) | Feb 02, 1987 | Substantially Equivalent | Microbiological Research Corp. |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Nov 28, 1986 | Substantially Equivalent | Diagnostic Technology, Inc. |
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Apr 24, 1986 | Substantially Equivalent | Immuno-Diagnostic Products, Inc. |
| K853484 | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT | Feb 05, 1986 | Substantially Equivalent | Biotech Research Laboratories, Inc. |
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | Dec 12, 1985 | Substantially Equivalent | Amico Lab, Inc. |
| K842530 | AMIZYME-EBV TEST KIT | Dec 06, 1985 | Substantially Equivalent | Amico Lab, Inc. |
| K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | May 05, 1981 | Substantially Equivalent | Electro-Nucleonics Laboratories, Inc. |
| K771062 | EBV TEST | Jul 14, 1977 | Substantially Equivalent | Gull Laboratories, Inc. |
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.