The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Toxo Igg Avidity.
| Device ID | K101946 |
| 510k Number | K101946 |
| Device Name: | VIDAS TOXO IGG AVIDITY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Marlene Chavaroche |
| Correspondent | Marlene Chavaroche BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-12 |
| Decision Date | 2011-05-18 |
| Summary: | summary |