HSA · registration DE0015964ORGENTEC Diagnostika Alegria Anti- Lactoferrin Test Strip
SingaporeImmunologyClass BORGENTEC Diagnostika GmbH
Official record identity
- Registration number
- DE0015964
- Model name
- Anti-Lactoferrin; ALEGRIA; Positive Control; Negative Control
- Model identifier
- ORG 227-24; ORG 300-00; ORG 310; ORG 311
- Registration date
- July 14, 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
Anti-Lactoferrin is an ELISA-based test system for the quantitative measurement of IgG class autoantibodies against lactoferrin 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.