Atlas FDA

MHI

27 FDA 510(k) clearances · Product code

105 daysmedian time to decision
262 days90th percentile
27clearances measured

FDA profile

Official device name
Giardia Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3220
Medical specialty
Microbiology
Adverse events (MAUDE)
1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
UNIGOLD GIARDIA (K120001)Trinity Biotech2013-03-01
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK (K103673)Techlab Inc., Corporate Research Center2011-08-18
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (K081064)Ivd Research, Inc.2009-01-14
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (K031942)Remel, Inc.2003-11-18
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (K031834)Remel, Inc.2003-11-10
GIARDIA II (K033274)Techlab, Inc.2003-11-04
IVD CRYPTO/GIARDIA DFA (K024113)Ivd Research, Inc.2003-03-05
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (K020583)Ivd Research, Inc.2002-09-17
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (K983399)Genzyme Diagnostics1999-01-11
PREMIER GIARDIA (K982711)Meridian Diagnostics, Inc.1998-11-25
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA (K982245)Biosite Incorporated1998-10-06
GIARDIA CELISA (K963135)Techlab, Inc.1996-11-29
CRYPTO/GIARDIA-CEL IF TEST (K955897)Techlab, Inc.1996-08-05
PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY (K955157)Alexon Biomedical, Inc.1996-02-09
TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) (K952467)Trend Scientific, Inc.1995-11-20
TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM (K953284)Trend Scientific, Inc.1995-10-06
LMD GIARDIA ANTIGEN DETECTION ASSAY (K944871)Lmd Laboratories1995-06-22
PROSPECT GIARDIA (K942098)Alexon, Inc.1994-09-09
PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION (K931147)Alexon, Inc.1993-05-13
PROSPEC T GIARDIA MICROTITER ASSAY (K930451)Alexon, Inc.1993-04-21
PROSPECT GIARDIA CONTROLS (K922675)Alexon, Inc.1992-09-11
PROSPECT(TM) GIARDIA MICROTITER ASSAY/MODIFICATION (K922010)Alexon, Inc.1992-06-19
MODIFICATION PROSPECT GIARDIA RAPID ASSAY (K920817)Alexon, Inc.1992-04-22
PROSPECT(TM) GIARDIA RAPID ASSAY (K915093)Alexon, Inc.1992-01-30
PROSPEC T/GIARDIA RAPID ASSAY (K911337)Alexon, Inc.1991-09-27
CELLABS GIARDIA CEL I.F. TEST (K912152)Celltech Diagnostics , Ltd.1991-08-12
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA (K912408)Meridian Diagnostics, Inc.1991-07-24

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Every clearance here is in the API, with alerts when new ones post.