FDA product code MHI: Giardia Spp.
MHI is the FDA product code for giardia spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel. FDA has cleared 27 510(k) submissions under MHI, from 13 different applicants. The average 510(k) review took 139 days (median 105). FDA has posted 6 recalls for MHI devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Giardia Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3220 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MHI clearance
Top MHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alexon, Inc. | 8 | 1994-09-09 |
| Ivd Research, Inc. | 3 | 2009-01-14 |
| Techlab, Inc. | 3 | 2003-11-04 |
| Remel, Inc. | 2 | 2003-11-18 |
| Meridian Diagnostics, Inc. | 2 | 1998-11-25 |
8 more applicants have MHI clearances. See the full list in Caduvo.
Most recent MHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K120001 | Trinity Biotech | UNIGOLD GIARDIA | 2013-03-01 | 423 |
| K103673 | Techlab Inc., Corporate Research Center | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | 2011-08-18 | 245 |
| K081064 | Ivd Research, Inc. | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF | 2009-01-14 | 275 |
| K031942 | Remel, Inc. | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | 2003-11-18 | 147 |
| K031834 | Remel, Inc. | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | 2003-11-10 | 150 |
Recalls for MHI devices
6 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code MHI?
MHI is the FDA product code for giardia spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel.
What device class is MHI?
Class II, regulation 21 CFR 866.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MHI?
Across 27 cleared submissions the average was 139 days from receipt to decision (median 105).
Which companies have the most MHI clearances?
Alexon, Inc. (8); Ivd Research, Inc. (3); Techlab, Inc. (3); Remel, Inc. (2); Meridian Diagnostics, Inc. (2).
Have MHI devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MHI
- Run a recall and safety report across every MHI manufacturer
- Watch product code MHI 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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