Antisera, Neutralization, Herpesvirus Hominis
FDA product code GQM · Class II (moderate risk) · 21 CFR 866.3305 · Microbiology
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K875367 | Colorgene Fluorescent DNA Hybridization Test / CMVGQM · Traditional | Enzo Biochem, Inc. | 03/28/1988SE |
| K810043 | Goat Anti-Herpes Simplex Virus Type IGQM · Traditional | Vibac Corp. | 05/15/1981SE |
| K791397 | Herpes Eia Test KitGQM · Traditional | Microbiological Assoc. | 09/24/1979SE |