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Panels › Microbiology › Product code LGD · Class 2

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Regulation 866.3780

0510(k)s in 12 months (106 all time)
0recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in LGD

Company510(k)sRecalls
Abbott Laboratories122
Beckman Coulter, Inc.70
Gull Laboratories, Inc.60
Labsystems, Inc.50
bioMerieux, Inc.22
Diamedix Corp.40
Zeus Scientific, Inc.40
Bayer Corp.30
Bio-Rad Laboratories21
Biomerieux Vitek, Inc.30
Decided510(k)Device and applicantCode
Sep 2, 1992K922585BARTELS TOXOPLASMA IGG EIA
Baxter Diagnostics, Inc.
LGD
Sep 2, 1992K922579BARTELS TOXOPLASMA IGM EIA
Baxter Diagnostics, Inc.
LGD
Jul 8, 1992K920702TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO
Pharmacia Diagnostics, Inc.
LGD
Apr 29, 1992K913731ENZYGNOST(R) TOXOPLASMOSIS/IGG
Behring Diagnostics, Inc.
LGD
Mar 4, 1992K915891TOXO IGG ELISA TEST (MODIFIED)
Gull Laboratories, Inc.
LGD
Mar 4, 1992K913505ENZYGNOST TOXOPLASMOSIS/IGM
Behring Diagnostics, Inc.
LGD
Jan 23, 1992K914852ELISA TOXO IGM
Sclavo, Inc.
LGD
Dec 18, 1991K913787TOXOPLASMA IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
LGD
Nov 29, 1991K913106ABBOTT IMX TOXO IGM POSITIVE CONTROL
Abbott Laboratories
LGD
Aug 12, 1991K911834OPUS(R) ROZO
Pb Diagnostic Systems, Inc.
LGD
Feb 26, 1991K910416ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
Abbott Laboratories
LGD
Dec 18, 1990K903968TOXO-CUBE
Difco Laboratories, Inc.
LGD
Oct 16, 1990K903324TOXO IGM ELISA TEST
Gull Laboratories, Inc.
LGD
Jul 24, 1990K902792TOXOPLASMA GONDII IGG
Pharmacia Diagnostics, Inc.
LGD
Apr 30, 1990K900818VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.
Vitek Systems, Inc.
LGD
Apr 16, 1990K900354TOXO IGG ELISA TEST
Gull Laboratories, Inc.
LGD
Mar 15, 1990K894948PLATELIA TOXO IGM KIT
Kallestad Diag, A Div. of Erbamont, Inc.
LGD
Mar 6, 1990K900655MODIFIED CAPTIA(R) TOXO-M
Mercia Diagnostics , Ltd., GB
LGD
Dec 18, 1989K893200DETECTADOT (TM) SYSTEM 2000 TOXO IGM TEST
Gull Laboratories, Inc.
LGD
Jul 14, 1989K891781TOXO ELISA TEST SYSTEM
Zeus Scientific, Inc.
LGD
Jun 23, 1989K890032IMX TOXO IGM ANTIBODY ASSAY
Abbott Laboratories
LGD
Jun 23, 1989K890031IMX TOXO IGG ANTIBODY ASSAY
Abbott Laboratories
LGD
Apr 12, 1989K885344IMMUNOCOMB(TM) TOXOPLASMA IGG ANTIBODY TEST KIT
Orgenics, Ltd.
LGD
Apr 10, 1989K884249MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT
Disease Detection International, Inc.
LGD
Feb 7, 1989K890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
Labsystems, Inc., FI
LGD
Feb 7, 1989K883937ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
Ortho Diagnostic Systems, Inc.
LGD
Jan 24, 1989K883720TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA
Lmd Laboratories
LGD
Oct 6, 1988K883936ORTHO* TOXOPLASMA-M ANTIBODY ELISA TEST
Ortho Diagnostic Systems, Inc.
LGD
Sep 30, 1988K875258TOXOPLASMA GONDII IGG ELISA KIT
De Ferris Laboratories, Inc.
LGD
Aug 1, 1988K880918CAPTIA TOXO-G
Mercia Diagnostics , Ltd., GB
LGD
Apr 21, 1988K875363SERODOT TOXOPLASMA IGG TEST KIT
Disease Detection International, Inc.
LGD
Apr 12, 1988K875113TOXOSTAT M TEST KIT
Whittaker Bioproducts, Inc.
LGD
Apr 12, 1988K873294BIOTROL TOXO ELISA TEST G
Biotrol, USA, Inc.
LGD
Apr 12, 1988K873293BIOTROL TOXO ELISA TEST M
Biotrol, USA, Inc.
LGD
Mar 7, 1988K875109DETECTADOT SYSTEM 2000 TOXO IGG TEST
Gull Laboratories, Inc.
LGD
Mar 7, 1988K874594TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560
Clinical Sciences, Inc.
LGD
Oct 20, 1987K872070CHROMOTITRE E.I.A. TOXOPLASMA IGM
Ismunit Istituto Immunologico Intaliano, IT
LGD
Jul 31, 1987K871746CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY
Mercia Diagnostics , Ltd., GB
LGD
Jul 30, 1987K871905TOXOPLASMA GONDII IGG ELISA
Electro-Nucleonics Laboratories, Inc.
LGD
Jul 1, 1987K872252MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
Labsystems, Inc.
LGD
Apr 28, 1987K870753TOXOPLASMA IGM MICROASSAY
Diamedix Corp.
LGD
Feb 20, 1987K865068ACCUPOINT TOXO
Syva Co.
LGD
Nov 28, 1986K863813TOXOPLASMA IGG MICROASSAY
Diamedix Corp.
LGD
Nov 13, 1986K863363CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY
Cytotech, Inc.
LGD
Sep 11, 1986K862196TOXONOSTIKA IGM MICROELISA SYSTEM
Organon Teknika Corp.
LGD
Sep 8, 1986K862189ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
Organon Teknika Corp.
LGD
Jun 30, 1986K862216TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
Labsystems, Inc.
LGD
Jun 13, 1986K861458MUREX SUDS TOXO
Murex Corp.
LGD
May 23, 1986K860773TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
Clinical Sciences, Inc.
LGD
Jul 9, 1985K850567ABBOTT TOXO-M EIA DIAGNOSTIC KIT
Abbott Laboratories
LGD

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