Product code MHI
- Device name
- Giardia Spp.
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3220
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K120001 | UNIGOLD GIARDIA | Trinity Biotech | 2013-03-01 |
| K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | Techlab Inc., Corporate Research Center | 2011-08-18 |
| K081064 | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF | Ivd Research, Inc. | 2009-01-14 |
| K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | Remel, Inc. | 2003-11-18 |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | Remel, Inc. | 2003-11-10 |
| K033274 | GIARDIA II | Techlab, Inc. | 2003-11-04 |
| K024113 | IVD CRYPTO/GIARDIA DFA | Ivd Research, Inc. | 2003-03-05 |
| K020583 | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 | Ivd Research, Inc. | 2002-09-17 |
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY | Genzyme Diagnostics | 1999-01-11 |
| K982711 | PREMIER GIARDIA | Meridian Diagnostics, Inc. | 1998-11-25 |
| K982245 | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA | Biosite Incorporated | 1998-10-06 |
| K963135 | GIARDIA CELISA | Techlab, Inc. | 1996-11-29 |
| K955897 | CRYPTO/GIARDIA-CEL IF TEST | Techlab, Inc. | 1996-08-05 |
| K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1996-02-09 |
| K952467 | TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) | Trend Scientific, Inc. | 1995-11-20 |
| K953284 | TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM | Trend Scientific, Inc. | 1995-10-06 |
| K944871 | LMD GIARDIA ANTIGEN DETECTION ASSAY | Lmd Laboratories | 1995-06-22 |
| K942098 | PROSPECT GIARDIA | Alexon, Inc. | 1994-09-09 |
| K931147 | PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION | Alexon, Inc. | 1993-05-13 |
| K930451 | PROSPEC T GIARDIA MICROTITER ASSAY | Alexon, Inc. | 1993-04-21 |
| K922675 | PROSPECT GIARDIA CONTROLS | Alexon, Inc. | 1992-09-11 |
| K922010 | PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION | Alexon, Inc. | 1992-06-19 |
| K920817 | MODIFICATION PROSPECT GIARDIA RAPID ASSAY | Alexon, Inc. | 1992-04-22 |
| K915093 | PROSPECT(TM) GIARDIA RAPID ASSAY | Alexon, Inc. | 1992-01-30 |
| K911337 | PROSPEC T/GIARDIA RAPID ASSAY | Alexon, Inc. | 1991-09-27 |
| K912152 | CELLABS GIARDIA CEL I.F. TEST | Celltech Diagnostics , Ltd. | 1991-08-12 |
| K912408 | MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA | Meridian Diagnostics, Inc. | 1991-07-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290115934298 | T-Handle with Pendulum Adaptor | PREMIA SPINE LTD | 2024-09-03 |
| 04048474059557 | 21-Hydroxylase Autoantibody ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474034776 | Giardia lamblia Antigen (stool) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239060594 | Giardia/Cryptosporidium Ag (stool) ELISA | DRG International Inc | 2023-08-26 |
| 00840239034779 | Giardia lamblia Antigen (stool) ELISA | DRG International Inc | 2023-08-24 |
| 00848838026683 | ProSpecT | REMEL, INC. | 2022-12-23 |
| 00083059150155 | EZ-GIARDIA One-Step Giardia Test | BIOMERICA, INC. | 2020-07-01 |
| 00083059070699 | Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2020-07-01 |
| 00857031002547 | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | 2019-05-31 |
| 00857031002400 | TRI-COMBO PARASITE SCREEN | TECHLAB, INC. | 2017-10-05 |
| 08305900070699 | Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2016-12-08 |
| 08305901501154 | EZ-GIARDIA One-Step Giardia Test | BIOMERICA, INC. | 2016-12-08 |
| 00848838026850 | NA | REMEL, INC. | 2016-09-24 |
| 00848838027000 | NA | OXOID LIMITED | 2016-09-24 |
| 00848838026867 | NA | REMEL, INC. | 2016-09-24 |
| 00848838026874 | NA | REMEL, INC. | 2016-09-24 |
| 00848838026881 | NA | REMEL, INC. | 2016-09-24 |
| 00848838026997 | NA | OXOID LIMITED | 2016-09-24 |
| 00848838027017 | NA | OXOID LIMITED | 2016-09-24 |
| 00613647000304 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2016-09-24 |
| 00840733101113 | MERIFLUOR Cryptosporidium/Giardia | MERIDIAN BIOSCIENCE, INC. | 2016-09-23 |
| 00893038002180 | Triage® | Alere San Diego, Inc. | 2016-09-21 |
| M445MCCCGDFA750 | Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay | MEDICAL CHEMICAL CORPORATION | 2016-09-20 |
| 05391516746328 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 05391516746335 | Trinity Biotech | MARDX DIAGNOSTICS, INC. | 2016-09-18 |
| 20885380096737 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-14 |
| 50885380096738 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-14 |
| 00857031002028 | GIARDIA II | TECHLAB, INC. | 2016-08-23 |
| 00857031002295 | GIARDIA II | TECHLAB, INC. | 2016-08-23 |
| 00857031002165 | GIARDIA/CRYPTOSPORIDIUM QUIK CHEK | TECHLAB, INC. | 2016-08-20 |