Antigen, Cf (Including Cf Control), Rubella
FDA product code GON · Class II (moderate risk) · 21 CFR 866.3510 · Microbiology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894262 | Rubella Antigen and Control AntigenGON · Traditional | Microbix Biosystems, Inc. | 10/16/1989SE |
| K880157 | Microtrak HSV 1/HSV 2 Culture Identi./Typing TestGON · Traditional | Syva Co. | 02/04/1988SE |
| K802939 | Herpes Simplex Type IGON · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
| K802937 | Rubella Virus Antigens & ControlsGON · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
| K780996 | Rubelisa Test KitGON · Traditional | Microbiological Assoc. | 11/22/1978SE |