HSA · registration DE0015983ORGENTEC Diagnostika Alegria Anti-Phospholipid IgM Test strip
SingaporeImmunologyClass BORGENTEC Diagnostika GmbH
Official record identity
- Registration number
- DE0015983
- Model name
- Anti-Phospholipid Screen IgM; Anti-Phosphatidyl Serine IgM; Anti-Phosphatidyl Inositol IgM; Anti-Phosphatidic Acid IgM; ALEGRIA; Positive Control; Negative Control
- Model identifier
- ORG 229M-24; ORG 235M-24; ORG 236M-24; ORG 237M-24; ORG 300-00; ORG 310; ORG 311
- Registration date
- July 15, 2014
- Source update date
- May 19, 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
An ELISA-based test system for the quantitative measurement of IgM class autoantibodies against cardiolipin, phosphatidyl serine, phosphatidyl inositol, phosphatidic acid and beta-2- glycoprotein I in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only.
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.