Antisera, Conjugated Fluorescent, Cytomegalovirus
FDA product code LIN · Class II (moderate risk) · 21 CFR 866.3175 · Microbiology
17510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Bartels Immunodiagnostic Supplies, Inc. 2
- Immuno Concepts, Inc. 2
- Baxter Healthcare Corp 2
- Biotest Diagnostics Corp. 2
- Immulok, Inc. 1
- Microbiological Research Corp. 1
- Pb Diagnostic Systems, Inc. 1
- Gull Laboratories, Inc. 1
- Incstar Corp. 1
- Diagnostic Products Corp. 1
- Light Diagnostics 1
- Organon Teknika Corp. 1
- Diagnostic Hybrids, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081164 | D3 Dfa Cytomegalovirus Immediate Early Antigen Identification KitLIN · Traditional | Diagnostic Hybrids, Inc. | 06/13/2008SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | Organon Teknika Corp. | 09/15/1999SE |
| K991650 | CMV Brite Turbo KitLIN · Special | Biotest Diagnostics Corp. | 07/12/1999SE |
| K951821 | Cytomegalovirus Direct Immunofluorescence AssayLIN · Traditional | Light Diagnostics | 06/07/1996SE |
| K951550 | CMV Brite Antigenemia Test KitLIN · Traditional | Biotest Diagnostics Corp. | 01/30/1996SE |
| K934798 | Pathodx CytomegalovirusLIN · Traditional | Diagnostic Products Corp. | 03/25/1994SE |
| K921616 | Cmv-Vue(Tm) CMV Antigen Detection KitLIN · Traditional | Incstar Corp. | 08/11/1992SN |
| K912592 | Cmv-Ea Mab TestLIN · Traditional | Gull Laboratories, Inc. | 12/04/1991SE |
| K905257 | Opus CMV Test SystemLIN · Traditional | Pb Diagnostic Systems, Inc. | 04/17/1991SE |
| K904036 | Bartels Cytomegalovirus Immed. Early AntigenLIN · Traditional | Baxter Healthcare Corp | 10/16/1990SE |
| K894002 | Cytomegalovirus Fluorescent Monoclonal AntibodyLIN · Traditional | Baxter Healthcare Corp | 08/10/1989SE |
| K893468 | CMV Igg Antibody Test (Indirect Fluorescent Test)LIN · Traditional | Immuno Concepts, Inc. | 07/14/1989SE |
| K893467 | CMV Igg Antibody Test (Indirect Enzyme Test)LIN · Traditional | Immuno Concepts, Inc. | 07/14/1989SE |
| K860279 | Cytomegalovirus Direct Fluorescent Antibody KitLIN · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 05/13/1986SE |
| K843138 | CMV TestLIN · Traditional | Microbiological Research Corp. | 01/29/1985SE |
| K822606 | Cytomegalovirus Antobody IggLIN · Traditional | Immulok, Inc. | 11/01/1982SE |
| K820895 | Cylomegalovirus Direct Fluorescent AntiLIN · Traditional | Bartels Immunodiagnostic Supplies, Inc. | 05/03/1982SE |