Product code GQH
- Device name
- Antigen, Cf (Including Cf Control), Cytomegalovirus
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3175
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K982311 | BARTELS CINAKIT CMV ANTIGENEMIA | Intracel Corp. | 1998-12-14 |
| K964875 | CMV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | 1997-03-18 |
| K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1994-05-05 |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | Stellar Bio Systems, Inc. | 1988-12-05 |
| K882024 | FITC MURINE MONOCLONAL ANTI-CMV IGG | Whittaker Bioproducts, Inc. | 1988-08-03 |
| K881932 | ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT | Ortho Diagnostic Systems, Inc. | 1988-08-01 |
| K880679 | BION CMV-G TEST SYSTEM | Bion Ent., Ltd. | 1988-06-03 |
| K880290 | MICROTRAK CMV CULTURE CONFIRMATION TEST | Syva Co. | 1988-04-19 |
| K872576 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION | Enzo Biochem, Inc. | 1987-12-04 |
| K873114 | CYTOMEGALOVIRUS CONTROL SLIDES | Medical Diagnostic Technologies, Inc. | 1987-09-25 |
| K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT | Serono Diagnostics, Inc. | 1987-02-19 |
| K843657 | CYTOMEGALOVIRUS | Institute Virion , Ltd. | 1985-09-26 |
| K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II | Clinical Sciences, Inc. | 1984-05-02 |
| K811671 | CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1981-09-16 |
| K802930 | CYTOMEGALO VIRUS & CONTROLS | Orion Diagnostica, Inc. | 1981-01-09 |
| K801963 | CMV TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-23 |
| K801722 | CMV BIO-BEAD TITRATION KIT | Litton Bionetics | 1980-09-16 |
| K791948 | FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS | Intl. Diagnostic Technology | 1979-11-16 |
| K791612 | CMV BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G5229021111 | Cytomegalovirus / CMV IgG IFA 96 Test | Hemagen Diagnostics, Inc. | 2023-10-06 |
| G5229021121 | Cytomegalovirus / CMV IgM IFA 96 Test | Hemagen Diagnostics, Inc. | 2023-10-06 |
| 04053252589768 | Light Diagnostics CMV Control Slides (5 pack) | EMD Millipore Corporation | 2020-04-17 |
| 04053252671074 | Light Diagnostics CMV IFA Reagent | EMD Millipore Corporation | 2020-04-17 |
| 04053252731730 | Light Diagnostics Anti-mouse IGG:FITC | EMD Millipore Corporation | 2020-04-17 |
| 04053252737183 | Light Diagnostics Mouse Anti-CMV Monoclonal Antibody | EMD Millipore Corporation | 2020-04-17 |
| 04061841047445 | Light Diagnostics CMV Control Slide | EMD Millipore Corporation | 2020-04-17 |
| 03573026390273 | ARGENE® CINAkit HCMV ppUL83 US | BIOMERIEUX SA | 2016-10-17 |
| 04053252676024 | Light Diagnostics™ CMV IFA Kit | EMD Millipore Corporation | 2016-09-26 |
| 00813545025489 | Cytomegalovirus IgG 120 Tests | SCIMEDX CORPORATION | 2016-09-20 |
| 00813545025502 | Cytomegalovirus 10wl/10 pk | SCIMEDX CORPORATION | 2016-09-20 |
| B110CM20120 | Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110CMG1200 | CMV IgG Test System, 120 Tests | Bion Enterprises, Ltd. | 2016-09-12 |
| B110CMG20200 | CMV IgG Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110CMM20300 | CMV IgM Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110CMN20100 | CMV Negative Control | Bion Enterprises, Ltd. | 2016-09-12 |