Svar Life Science AB
MALMO Skane, SE
Svar Life Science AB appears in FDA device records in MALMO Skane, SE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Svar Life Science AB carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Euro-Diagnostica AB510(k), enforcement report, recall
510(k) clearance history
FDA records hold 6 510(k) clearances for Svar Life Science AB between 1997 and 2010. The busiest year on record is 1997, with 3. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 2006 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093908 | CCPOINT | NHX | Substantially Equivalent | |
| K091657 | IMMUNOSCAN CCPLUS | NHX | Substantially Equivalent | |
| K062045 | EDIA ANTI-CCP | NHX | Substantially Equivalent | |
| K971690 | IMMUNOSCAN PR3-ANCA | MOB | Substantially Equivalent | |
| K971689 | IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT | MOB | Substantially Equivalent | |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | DBL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616003 | 3007610287 | Svar Life Science AB | Lundavagen 151, MALMO Skane SE-212 24 SE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2627-2017 | 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 serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens. | FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date. | Class III | Terminated | |
| Z-0306-2018 | 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 definition of specific antibody profiles is a valuable aid in the diagnostic process. | Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples. | Class II | Terminated | |
| Z-2922-2018 | 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 to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process. | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Terminated | |
| Z-2921-2018 | 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 heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders. | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Terminated | |
| Z-2920-2018 | 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 heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG autoantibody levels in patients where this information is useful in diagnosis, particularly in the assessment of thrombotic risk in patients with systemic lupus erythematosus, or other lupus-like disorders | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Terminated | |
| Z-2919-2018 | 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, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic diseases, particularly Sjgren's syndrome and is not definitive in isolation. Autoantibody levels represent one parameter in a multi-criterion diagnostic process. | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | Class III | Terminated | |
| Z-2918-2018 | 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. | Decreasing performance overtime. | Class II | Terminated | |
| Z-0929-2018 | 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) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process. | Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the strong IgM conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two FANA200 kit lots SS 1500 and SS 2009. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain