FDA product code MCE: Respiratory Syncytial Virus - Elisa
MCE is the FDA product code for respiratory syncytial virus - elisa. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MCE, from 2 different applicants. The average 510(k) review took 162 days (median 162).
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Syncytial Virus - Elisa |
| Device class | Class I |
| Regulation | 21 CFR 866.3480 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MCE clearance
Top MCE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quidel Corp. | 1 | 2006-09-08 |
| Bio-Rad Laboratories, Inc. | 1 | 1993-02-12 |
Most recent MCE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061008 | Quidel Corp. | QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 | 2006-09-08 | 149 |
| K924289 | Bio-Rad Laboratories, Inc. | KALLESTAD RSV MICROPLATE EIA | 1993-02-12 | 175 |
Recalls for MCE devices
openFDA lists no recalls for product code MCE.
Frequently asked questions
What is FDA product code MCE?
MCE is the FDA product code for respiratory syncytial virus - elisa. It is a Class I device, regulated under 21 CFR 866.3480 and reviewed by the Microbiology panel.
What device class is MCE?
Class I, regulation 21 CFR 866.3480. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MCE?
Across 2 cleared submissions the average was 162 days from receipt to decision (median 162).
Which companies have the most MCE clearances?
Quidel Corp. (1); Bio-Rad Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MCE
- Run a recall and safety report across every MCE manufacturer
- Watch product code MCE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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