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)
Top companies in MID
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2023 | Bio-Rad Laboratories, Inc. BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack Open, Classified |
MID | K130528 |
| Aug 23, 2018 | Euro 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 |
MID | K001574 |
| Aug 23, 2018 | Euro 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 |
MID | K001574 |
| Aug 28, 2012 | Phadia US Inc PHADIA Varelisa Cardiolipin IgM
Cardiolipin autoantibody immunological test system (IgM class antibodies) Terminated |
MID | K020758 |
| Mar 5, 2010 | Calbiotech 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 |
MID | None listed |
| Oct 4, 2007 | Louisville 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 |
MID | K933588 |
| Aug 17, 2007 | Louisville 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 |
MID | K933588 |
| Aug 17, 2007 | Louisville 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 |
MID | K933588 |
| Aug 17, 2007 | Louisville 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 |
MID | K933588 |
| Jul 24, 2007 | Louisville 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 |
MID | K933588 |
| Jul 24, 2007 | Louisville 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 |
MID | K933588 |
| May 4, 2006 | Thera 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 |
MID | K060176 |
| Jun 25, 2005 | Diasorin 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 |
MID | K001981 |
| Mar 18, 2005 | Diasorin 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 |
MID | K001981 |
| Nov 20, 2004 | Zeus 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 |
MID | K981021 |
| Aug 21, 2003 | Zeus Scientific Inc Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO. Terminated |
MID | K984173 |
| Jun 21, 2003 | Binding Site Inc The Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029 Terminated |
MID | K983694 |
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