Company ยท US
Euro Diagnostica AB
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2010. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LKJ | Antinuclear Antibody, Antigen, Control | 4 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 4 |
| MID | System, Test, Anticardiolipin Immunological | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 1, 2010 | K093908 | CCPOINT Euro-Diagnostica AB | NHX |
| Nov 19, 2009 | K091657 | IMMUNOSCAN CCPLUS Euro-Diagnostica AB, SE | NHX |
| Dec 4, 2006 | K062045 | EDIA ANTI-CCP Euro-Diagnostica AB, SE | NHX |
| Oct 29, 1997 | K971690 | IMMUNOSCAN PR3-ANCA Euro-Diagnostica AB | MOB |
| Oct 29, 1997 | K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT Euro-Diagnostica AB | MOB |
| Oct 29, 1997 | K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT Euro-Diagnostica AB | DBL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2018 | Euro Diagnostica AB Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. Terminated |
NHX | K091657 |
| Aug 23, 2018 | Euro Diagnostica AB is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended Terminated |
LKJ | K912291 |
| 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 23, 2018 | Euro Diagnostica AB is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrate Terminated |
LKO | K905194 |
| Dec 20, 2017 | Euro Diagnostica AB Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA
DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definit Terminated |
LKJ | K932876 |
| May 22, 2017 | Euro Diagnostica AB DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human s Terminated |
LKJ | K932876 |
| Oct 15, 2015 | Euro Diagnostica AB DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200.
Product Usage:
The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA Terminated |
LKJ | K932876 |