Panels › Microbiology › Product code MHI · Class 2
Giardia Spp.
Regulation 866.3220
0510(k)s in 12 months (27 all time)
1recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in MHI
| Company | 510(k)s | Recalls |
|---|---|---|
| Alexon, Inc. | 8 | 0 |
| Remel, Inc. | 2 | 3 |
| Ivd Research, Inc. | 3 | 0 |
| Techlab, Inc. | 3 | 0 |
| Genzyme Diagnostics | 1 | 1 |
| Meridian Diagnostics, Inc. | 2 | 0 |
| Trend Scientific, Inc. | 2 | 0 |
| Alexon Biomedical, Inc. | 1 | 0 |
| Biosite Incorporated | 1 | 0 |
| Celltech Diagnostics , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Parasite Test Open, Classified |
MHI | None listed |
| May 2, 2025 | MEDLINE INDUSTRIES, LP - Northfield Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830 Open, Classified |
MHI | K983399 |
| Sep 19, 2008 | Remel, Inc Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use.
A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal spec Terminated |
MHI | K031834 |
| Aug 17, 2004 | Remel, Inc. ProSpecT Giardia/Cryptosporidium Microplate Assay. Catalog #: 2458496. Terminated |
MHI | K955157 |
| Aug 17, 2004 | Remel, Inc. ProSpecT Giardia/Cryptosporidium Micorplate Assay. Catalog #: 2458496. Terminated |
MHI | K955157 |
| Jul 20, 2004 | Genzyme Diagnostics Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits.
These are sold under two names as follows:
Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac G Terminated |
MHI | K983399 |
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