Antigen, Cf (Including Cf Control), Cytomegalovirus
FDA product code GQH · Class II (moderate risk) · 21 CFR 866.3175 · Microbiology
19510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Litton Bionetics 2
- Enzo Biochem, Inc. 1
- Intracel Corp. 1
- Viral Antigens, Inc. 1
- Light Diagnostics 1
- Stellar Bio Systems, Inc. 1
- Whittaker Bioproducts, Inc. 1
- Ortho Diagnostic Systems, Inc. 1
- Bion Ent., Ltd. 1
- Syva Co. 1
- Medical Diagnostic Technologies, Inc. 1
- Serono Diagnostics, Inc. 1
- Institute Virion , Ltd. 1
- Clinical Sciences, Inc. 1
- Zeus Scientific, Inc. 1
- Orion Diagnostica, Inc. 1
- Immuno-Diagnostic Products, Inc. 1
- Intl. Diagnostic Technology 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K982311 | Bartels Cinakit CMV AntigenemiaGQH · Traditional | Intracel Corp. | 12/14/1998SE |
| K964875 | CMV Antigen Control SlidesGQH · Traditional | Viral Antigens, Inc. | 03/18/1997SE |
| K935809 | Cytomegalovirus Indirect Immunofluorescence AssayGQH · Traditional | Light Diagnostics | 05/05/1994SE |
| K882835 | Indirect Fluorescent Assay for (HCMV)GQH · Traditional | Stellar Bio Systems, Inc. | 12/05/1988SE |
| K882024 | Fitc Murine Monoclonal Anti-Cmv IggGQH · Traditional | Whittaker Bioproducts, Inc. | 08/03/1988SE |
| K881932 | Ortho* Cytomegalovirus Identification ReagentGQH · Traditional | Ortho Diagnostic Systems, Inc. | 08/01/1988SE |
| K880679 | Bion Cmv-G Test SystemGQH · Traditional | Bion Ent., Ltd. | 06/03/1988SE |
| K880290 | Microtrak CMV Culture Confirmation TestGQH · Traditional | Syva Co. | 04/19/1988SE |
| K872576 | Colorgene DNA Hybridization Test CMV ConfirmationGQH · Traditional | Enzo Biochem, Inc. | 12/04/1987SE |
| K873114 | Cytomegalovirus Control SlidesGQH · Traditional | Medical Diagnostic Technologies, Inc. | 09/25/1987SE |
| K864565 | Monabrite Cytomegalovirus (CMV) Ifa KitGQH · Traditional | Serono Diagnostics, Inc. | 02/19/1987SE |
| K843657 | CytomegalovirusGQH · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K833089 | Cytomegalovirus Antibody Fluoro-Kit IIGQH · Traditional | Clinical Sciences, Inc. | 05/02/1984SE |
| K811671 | Cytomegalovirus Antibody Test SystemGQH · Traditional | Zeus Scientific, Inc. | 09/16/1981SE |
| K802930 | Cytomegalo Virus & ControlsGQH · Traditional | Orion Diagnostica, Inc. | 01/09/1981SE |
| K801963 | CMV Test KitGQH · Traditional | Immuno-Diagnostic Products, Inc. | 10/23/1980SE |
| K801722 | CMV Bio-Bead Titration KitGQH · Traditional | Litton Bionetics | 09/16/1980SE |
| K791948 | Fiax Test Kit for Anti-CytomegalorirusGQH · Traditional | Intl. Diagnostic Technology | 11/16/1979SE |
| K791612 | CMV Bio-Bead Screen KitGQH · Traditional | Litton Bionetics | 11/13/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1478-2013 Class III | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a…Affected products have a labeled expiration date of one year too long. | Bion Enterprises Ltd | 01/23/2013Terminated |