Is this your brand? Sign in to claim ownership.
Sign in to claim this brandEuro-Diagnostica AB
US
Last updated May 23, 2026
What Euro-Diagnostica AB makes
Euro-Diagnostica AB manufactures in vitro diagnostic (IVD) enzyme immunoassay kits and reagents for the detection of various antibodies. Their product portfolio includes assays for cyclic citrullinated peptide, anticardiolipin, extractable nuclear antigen, vasculitis-associated, glomerular basement membrane, Jo-1, and thyroid peroxidase antibodies, as well as glucagon and gastrin reagents.
The company is based in the US, and its devices are categorized as Class I and Class II medical devices. These products are listed in the FDA 510(k) clearance database and the FDA Unique Device Identification (UDI) system.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Euro-Diagnostica AB manufacture?
Euro-Diagnostica AB manufactures in vitro diagnostic (IVD) enzyme immunoassay kits and reagents. Their product portfolio focuses on the detection of various antibodies, including cyclic citrullinated peptide, anticardiolipin, extractable nuclear antigen, vasculitis-associated, glomerular basement membrane, Jo-1, and thyroid peroxidase antibodies, alongside specific reagents for glucagon and gastrin.
Where is Euro-Diagnostica AB based?
Euro-Diagnostica AB is based in the United States. This location information is provided as part of the company's regulatory profile data.
How are the devices from Euro-Diagnostica AB classified?
The devices manufactured by Euro-Diagnostica AB are classified as Class I and Class II medical devices. These classifications are determined based on the regulatory requirements for the specific in vitro diagnostic kits and reagents the company produces.
Which regulatory registries list the devices produced by Euro-Diagnostica AB?
The devices from Euro-Diagnostica AB are listed in the FDA 510(k) clearance database and the FDA Unique Device Identification (UDI) system. These registries are used to track medical devices that have undergone the necessary regulatory review processes for the US market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 559894501
Catalogue (37)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DIASTAT anti-Cardiolipin IgM | FCAR100M | FDA UDI | Class II | Active |
| EURIA Gastrin | MD302 | FDA UDI | Class I | Active |
| DIASTAT ENA Profile | FAID200 | FDA UDI | Class II | Active |
| DIASTAT anti-B2-Glycoprotein-1 IgM | FBGP100 | FDA UDI | Class II | Active |
| DIASTAT anti-Jo-1 | FAJO200 | FDA UDI | Class II | Active |
| WIESLAB ANCA Screen kit | CP111 | FDA UDI | Class II | Active |
| EDIA anti-CCP | FCCP100 | FDA UDI | Class II | Active |
| DIASTAT ENA Single Well Screen | FSWS200 | FDA UDI | Class II | Active |
| DIASTST anti-Sm | FASM200 | FDA UDI | Class II | Active |
| WIESLAB anti-GBM semi quantitative kit | GP104X | FDA UDI | Class II | Active |
| DIASTAT anti-Thyroid Peroxidase | FTPO300 | FDA UDI | Class II | Active |
| Diastat Ana | FANA200 | FDA UDI | Class II | Active |
| EURIA Glucagon | RB310 | FDA UDI | Class I | Active |
| DIASTAT anti-Sm/RNP | FRNP200 | FDA UDI | Class II | Active |
| DIASTAT anti-Mitochondrial | FMIT200 | FDA UDI | Class II | Active |
| DIASTAT anti-dsDNA | FDNA100 | FDA UDI | Class II | Active |
| DIASTAT anti-Cardiolipin IgG | FCAR100G | FDA UDI | Class II | Active |
| WIESLAB antiGBM, ANCA Screen kit | GCP100 | FDA UDI | Class II | Active |
| CCPoint | CCPoint20US | FDA UDI | Class II | Active |
| DIASTAT anti-La (SS-B) | FALA200 | FDA UDI | Class II | Active |
| IMMUNOSCAN CCPlus | RA-96PLUS | FDA UDI | Class II | Active |
| WIESLAB Capture PR3 ANCA | CapPR3 US | FDA UDI | Class II | Active |
| WIESLAB Capture MPO-ANCA | CapMPO US | FDA UDI | Class II | Active |
| DIASTAT anti-B2 Glycoprotein-1 IgG | FBGP200 | FDA UDI | Class II | Active |
| DIASTAT anti-Ro (SS-A) | FARO300 | FDA UDI | Class II | Active |
| DIASTAT anti-thyroglobulin | FATG200 | FDA UDI | Class II | Active |
| DIASTAT anti-SCL-70 | FSCL200 | FDA UDI | Class II | Active |
| DIASTAT total anti-Cardiolipin | FCAR100T | FDA UDI | Class II | Active |
| Wieslab Cap Pr-3 Anca | K051458 | FDA 510(k) | Class II | Active |
| Immunoscan Pr3-Anca | K971690 | FDA 510(k) | Class II | Active |
| Immunoscan Anti-Gbm Quantitative Kit | K971464 | FDA 510(k) | Class II | Active |
| Immunoscan Ra Anti-Ccp Test System | K052133 | FDA 510(k) | Class II | Active |
| Edia Anti-Ccp | K062045 | FDA 510(k) | Class II | Active |
| Immunoscan Ccplus | K091657 | FDA 510(k) | Class II | Active |
| Immunoscan Anti-Myeloperoxidase Antibodies (mpo-Anca) Quantitative Kit | K971689 | FDA 510(k) | Class II | Active |
| Wieslab Cap Mpo-Anca | K051455 | FDA 510(k) | Class II | Active |
| Ccpoint | K093908 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
There are 8 recall records for Euro-Diagnostica AB initiated between 2015-10-15 and 2017-05-22, all of which are currently terminated. The reasons provided for these recalls include component deviations, decreasing performance over time, shortened shelf-life, high background in ELISA plates, and incorrect labeling regarding manufacturing and distribution information.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 22, 2017 | Z-2627-2017 | — | terminated | 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. |
| Feb 14, 2017 | Z-0306-2018 | — | terminated | 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. |
| Oct 21, 2016 | Z-2922-2018 | — | terminated | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| Oct 21, 2016 | Z-2920-2018 | — | terminated | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| Oct 21, 2016 | Z-2919-2018 | — | terminated | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| Oct 21, 2016 | Z-2921-2018 | — | terminated | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| Feb 14, 2016 | Z-2918-2018 | — | terminated | Decreasing performance overtime. |
| Oct 15, 2015 | Z-0929-2018 | — | terminated | 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. |