Home › Device types › MHI
Giardia Spp.
FDA product code MHI · Class 2 · Microbiology
30
Registered devices
2
Adverse events
6
Recalls
27
510(k) clearances
Devices with this code
Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay — MEDICAL CHEMICAL CORPORATIONNA — REMEL, INC.GIARDIA/CRYPTOSPORIDIUM QUIK CHEK — TECHLAB, INC.Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] — BIOMERICA, INC.GIARDIA II — TECHLAB, INC.NA — REMEL, INC.Giardia lamblia Antigen (stool) ELISA — DRG International IncGiardia/Cryptosporidium Ag (stool) ELISA — DRG International IncNA — OXOID LIMITEDEZ-GIARDIA One-Step Giardia Test — BIOMERICA, INC.Giardia lamblia Antigen (stool) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTRI-COMBO PARASITE SCREEN — TECHLAB, INC.T-Handle with Pendulum Adaptor — PREMIA SPINE LTDEZ-GIARDIA One-Step Giardia Test — BIOMERICA, INC.CARDINAL HEALTH — Cardinal Health 200, LLCTRI-COMBO PARASITE SCREEN — TECHLAB, INC.NA — REMEL, INC.21-Hydroxylase Autoantibody ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungTrinity Biotech — MARDX DIAGNOSTICS, INC.GIARDIA II — TECHLAB, INC.NA — OXOID LIMITEDMERIFLUOR Cryptosporidium/Giardia — MERIDIAN BIOSCIENCE, INC.NA — REMEL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-03-24 | MEDLINE INDUSTRIES, LP - Northfield | A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requi |
| 2008-08-11 | Remel, Inc | Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive |
| 2004-02-23 | Genzyme Diagnostics | False Positive results. |
| 2003-12-09 | Remel, Inc. | The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run. |
| 2002-11-21 | Remel, Inc. | The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the conta |
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