The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Rub Igg.
| Device ID | K080766 |
| 510k Number | K080766 |
| Device Name: | VIDAS RUB IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Contact | Nikita S Mapp |
| Correspondent | Nikita S Mapp BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-18 |
| Decision Date | 2008-12-23 |
| Summary: | summary |