MCE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Respiratory Syncytial Virus - Elisa
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 (K061008) | Quidel Corp. | 2006-09-08 |
| KALLESTAD RSV MICROPLATE EIA (K924289) | Bio-Rad Laboratories, Inc. | 1993-02-12 |
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