Igg (Fd Fragment Specific), Antigen, Antiserum, Control
FDA product code DAQ · Class I (low risk) · 21 CFR 866.5540 · Immunology
1510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891299 | Mid-Level Igg Kit Cat. No. 9315DAQ · Traditional | Helena Laboratories | 03/22/1989SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1147-2019 Class II | Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190…New endogenous interference claims have been established for the following assays used on the cobas c 311… | Roche Diagnostics Corporation | 12/17/2018Terminated |