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Panels › Immunology › Product code MID · Class 2

System, Test, Anticardiolipin Immunological

Regulation 866.5660

0510(k)s in 12 months (94 all time)
0recalls in 12 months (17 all time)
16recalls that name a 510(k)
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Top companies in MID

DateFirm and productCodeLinked 510(k)
May 10, 2023Bio-Rad Laboratories, Inc.
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Open, Classified
MIDK130528
Aug 23, 2018Euro Diagnostica AB
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium hepar
Terminated
MIDK001574
Aug 23, 2018Euro Diagnostica AB
is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium hepar
Terminated
MIDK001574
Aug 28, 2012Phadia US Inc
PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
Terminated
MIDK020758
Mar 5, 2010Calbiotech Inc
Cardiolipin IgM ELISA 96 Well Kit, Catalog Number: CA036M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Terminated
MIDNone listed
Oct 4, 2007Louisville Apl Diagnostics Inc
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
Terminated
MIDK933588
Aug 17, 2007Louisville Apl Diagnostics Inc
APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current a
Terminated
MIDK933588
Aug 17, 2007Louisville Apl Diagnostics Inc
APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc.-- (current ad
Terminated
MIDK933588
Aug 17, 2007Louisville Apl Diagnostics Inc
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (addres
Terminated
MIDK933588
Jul 24, 2007Louisville Apl Diagnostics Inc
american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77
Terminated
MIDK933588
Jul 24, 2007Louisville Apl Diagnostics Inc
american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77
Terminated
MIDK933588
May 4, 2006Thera Test Laboratories, Inc.
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard,
Terminated
MIDK060176
Jun 25, 2005Diasorin Inc.
DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.
Terminated
MIDK001981
Mar 18, 2005Diasorin Inc.
DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwester
Terminated
MIDK001981
Nov 20, 2004Zeus Scientific Inc
Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, subst
Terminated
MIDK981021
Aug 21, 2003Zeus Scientific Inc
Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
Terminated
MIDK984173
Jun 21, 2003Binding Site Inc The
Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029
Terminated
MIDK983694

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