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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 2013 | K120001 | UNIGOLD GIARDIA Trinity Biotech | MHI |
| Aug 18, 2011 | K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK Techlab Inc., Corporate Research Center | MHI |
| Jan 14, 2009 | K081064 | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF Ivd Research, Inc. | MHI |
| Nov 18, 2003 | K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 Remel, Inc. | MHI |
| Nov 10, 2003 | K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY Remel, Inc. | MHI |
| Nov 4, 2003 | K033274 | GIARDIA II Techlab, Inc. | MHI |
| Mar 5, 2003 | K024113 | IVD CRYPTO/GIARDIA DFA Ivd Research, Inc. | MHI |
| Sep 17, 2002 | K020583 | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 Ivd Research, Inc. | MHI |
| Jan 11, 1999 | K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY Genzyme Diagnostics | MHI |
| Nov 25, 1998 | K982711 | PREMIER GIARDIA Meridian Diagnostics, Inc. | MHI |
| Oct 6, 1998 | K982245 | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA Biosite Incorporated | MHI |
| Nov 29, 1996 | K963135 | GIARDIA CELISA Techlab, Inc. | MHI |
| Aug 5, 1996 | K955897 | CRYPTO/GIARDIA-CEL IF TEST Techlab, Inc. | MHI |
| Feb 9, 1996 | K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY Alexon Biomedical, Inc. | MHI |
| Nov 20, 1995 | K952467 | TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) Trend Scientific, Inc. | MHI |
| Oct 6, 1995 | K953284 | TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM Trend Scientific, Inc. | MHI |
| Jun 22, 1995 | K944871 | LMD GIARDIA ANTIGEN DETECTION ASSAY Lmd Laboratories | MHI |
| Sep 9, 1994 | K942098 | PROSPECT GIARDIA Alexon, Inc. | MHI |
| May 13, 1993 | K931147 | PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION Alexon, Inc. | MHI |
| Apr 21, 1993 | K930451 | PROSPEC T GIARDIA MICROTITER ASSAY Alexon, Inc. | MHI |
| Sep 11, 1992 | K922675 | PROSPECT GIARDIA CONTROLS Alexon, Inc. | MHI |
| Jun 19, 1992 | K922010 | PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION Alexon, Inc. | MHI |
| Apr 22, 1992 | K920817 | MODIFICATION PROSPECT GIARDIA RAPID ASSAY Alexon, Inc. | MHI |
| Jan 30, 1992 | K915093 | PROSPECT(TM) GIARDIA RAPID ASSAY Alexon, Inc. | MHI |
| Sep 27, 1991 | K911337 | PROSPEC T/GIARDIA RAPID ASSAY Alexon, Inc. | MHI |
| Aug 12, 1991 | K912152 | CELLABS GIARDIA CEL I.F. TEST Celltech Diagnostics , Ltd. | MHI |
| Jul 24, 1991 | K912408 | MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA Meridian Diagnostics, Inc. | MHI |
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