FDA product code MIU: Enzyme Linked Immunosorbent Assay, T. Cruzi
MIU is the FDA product code for enzyme linked immunosorbent assay, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under MIU, from 6 different applicants. The average 510(k) review took 490 days (median 477). FDA has posted 1 recall for MIU devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunosorbent Assay, T. Cruzi |
| Device class | Class I |
| Regulation | 21 CFR 866.3870 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MIU clearance
Top MIU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| InBios International, Inc. | 1 | 2016-12-16 |
| Ortho-Clinical Diagnostics, Inc. | 1 | 2009-04-15 |
| Wiener Laboratories Saic | 1 | 2004-02-11 |
| Hemagen Diagnostics, Inc. | 1 | 1995-05-19 |
| Abbott Laboratories | 1 | 1994-12-19 |
1 more applicants have MIU clearances. See the full list in Caduvo.
Most recent MIU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161947 | InBios International, Inc. | Chagas Detect Plus Rapid Test | 2016-12-16 | 155 |
| K072732 | Ortho-Clinical Diagnostics, Inc. | ORTHO T. CRUZI ELISA TEST SYSTEM | 2009-04-15 | 567 |
| K023889 | Wiener Laboratories Saic | WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 | 2004-02-11 | 447 |
| K930272 | Hemagen Diagnostics, Inc. | HEMAGEN CHAGAS' KIT (EIA METHOD) | 1995-05-19 | 850 |
| K933716 | Abbott Laboratories | ABBOTT CHAGAS ANTIBODY EIA | 1994-12-19 | 507 |
Recalls for MIU devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2017-11-10.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code MIU?
MIU is the FDA product code for enzyme linked immunosorbent assay, t. cruzi. It is a Class I device, regulated under 21 CFR 866.3870 and reviewed by the Microbiology panel.
What device class is MIU?
Class I, regulation 21 CFR 866.3870. Typical premarket route: 510(k).
How long does a 510(k) take for product code MIU?
Across 6 cleared submissions the average was 490 days from receipt to decision (median 477).
Which companies have the most MIU clearances?
InBios International, Inc. (1); Ortho-Clinical Diagnostics, Inc. (1); Wiener Laboratories Saic (1); Hemagen Diagnostics, Inc. (1); Abbott Laboratories (1).
Have MIU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-11-10.
Next steps
- Run an FDA pathway report with predicate devices for product code MIU
- Run a recall and safety report across every MIU manufacturer
- Watch product code MIU 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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