HSA · registration DE0015903ORGENTEC Diagnostika Anti-Phospholipid IgG/IgM kits
SingaporeImmunologyClass BORGENTEC Diagnostika GmbH
Official record identity
- Registration number
- DE0015903
- Model name
- Anti-Phospholipid Screen IgG/IgM; Anti-Phosphatidyl Serine IgG/IgM; Anti-Phosphatidyl Inositol IgG/IgM; Anti-Phosphatidic Acid IgG/IgM
- Model identifier
- ORG 529; ORG 535; ORG 536; ORG 537
- Registration date
- July 09, 2014
- Source update date
- March 05, 2026
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- ORGENTEC Diagnostika GmbH
- Registrant / registration holder
- SEBIA SINGAPORE PTE. LTD.
Official description
Quantitative enzyme immunoassay (EIA) intended to screen for the presence of IgG and IgM class autoantibodies against cardiolipin, phosphatidyl serine, phosphatidyl inositol, phosphatidic acid and beta-2-glycoprotein I in human serum or plasma as an aid in the diagnosis of an increased risk of thrombosis in patients with systemic lupus erythematosus (SLE) or lupus-like disorders.
Additional source fields
- Product owner address
- Carl-Zeiss-Strasse 49-51, 55129 Mainz, Mainz, Rheinland-Pfalz, Germany
- Registrant address
- 51 CHANGI BUSINESS PARK CENTRAL 2, #09-12, THE SIGNATURE, Singapore 486066
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.