Panels › Microbiology › Product code GQH · Class 2
Antigen, Cf (Including Cf Control), Cytomegalovirus
Regulation 866.3175
0510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GQH
| Company | 510(k)s | Recalls |
|---|---|---|
| Litton Bionetics | 2 | 0 |
| Bion Ent., Ltd. | 1 | 0 |
| Bion Enterprises Ltd | 0 | 1 |
| Clinical Sciences, Inc. | 1 | 0 |
| Enzo Biochem, Inc. | 1 | 0 |
| Immuno-Diagnostic Products, Inc. | 1 | 0 |
| Institute Virion , Ltd. | 1 | 0 |
| Intl. Diagnostic Technology | 1 | 0 |
| Intracel Corp. | 1 | 0 |
| Light Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 1998 | K982311 | BARTELS CINAKIT CMV ANTIGENEMIA Intracel Corp. | GQH |
| Mar 18, 1997 | K964875 | CMV ANTIGEN CONTROL SLIDES Viral Antigens, Inc. | GQH |
| May 5, 1994 | K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY Light Diagnostics | GQH |
| Dec 5, 1988 | K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) Stellar Bio Systems, Inc. | GQH |
| Aug 3, 1988 | K882024 | FITC MURINE MONOCLONAL ANTI-CMV IGG Whittaker Bioproducts, Inc. | GQH |
| Aug 1, 1988 | K881932 | ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT Ortho Diagnostic Systems, Inc. | GQH |
| Jun 3, 1988 | K880679 | BION CMV-G TEST SYSTEM Bion Ent., Ltd. | GQH |
| Apr 19, 1988 | K880290 | MICROTRAK CMV CULTURE CONFIRMATION TEST Syva Co. | GQH |
| Dec 4, 1987 | K872576 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION Enzo Biochem, Inc. | GQH |
| Sep 25, 1987 | K873114 | CYTOMEGALOVIRUS CONTROL SLIDES Medical Diagnostic Technologies, Inc. | GQH |
| Feb 19, 1987 | K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT Serono Diagnostics, Inc. | GQH |
| Sep 26, 1985 | K843657 | CYTOMEGALOVIRUS Institute Virion , Ltd. | GQH |
| May 2, 1984 | K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II Clinical Sciences, Inc. | GQH |
| Sep 16, 1981 | K811671 | CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM Zeus Scientific, Inc. | GQH |
| Jan 9, 1981 | K802930 | CYTOMEGALO VIRUS & CONTROLS Orion Diagnostica, Inc. | GQH |
| Oct 23, 1980 | K801963 | CMV TEST KIT Immuno-Diagnostic Products, Inc. | GQH |
| Sep 16, 1980 | K801722 | CMV BIO-BEAD TITRATION KIT Litton Bionetics | GQH |
| Nov 16, 1979 | K791948 | FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS Intl. Diagnostic Technology | GQH |
| Nov 13, 1979 | K791612 | CMV BIO-BEAD SCREEN KIT Litton Bionetics | GQH |
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