Data / Medical devices / Sweden / Svar Life Science AB
Svar Life Science AB: FDA-registered device maker in MALMO Skane, Sweden, 1 510(k) clearance
Svar Life Science AB is registered with the FDA (registration 9616003) in MALMO Skane, Sweden. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2009. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616003
- FEI number
- 3007610287
- Address
- Lundavagen 151, MALMO Skane, Sweden, SE-212 24
- Owner or operator
- Svar Life Science AB (9030111)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2026
- Brand names listed
- Immunoscan CCPlus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | NHX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | DBM | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2009 | K091657 | IMMUNOSCAN CCPLUS | NHX | Substantially Equivalent | Euro-Diagnostica AB | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 22, 2017 | 77426 | Class III | Terminated | 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. | 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 da | accessdata.fda.gov |
| February 14, 2017 | 77107 | Class II | Terminated | 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 antib | 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. | accessdata.fda.gov |
| October 21, 2016 | 80684 | Class III | Terminated | 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 inte | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. | accessdata.fda.gov |
| February 14, 2016 | 80689 | Class II | Terminated | 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. | accessdata.fda.gov |
| October 15, 2015 | 79183 | Class II | Terminated | 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 o | 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 200 | accessdata.fda.gov |
Compare with other makers
- All makers of Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- All makers of Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Updated November 19, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.