HSA · registration DE0509831Technoclone Ak-Calibrant
SingaporeHematologyClass CTechnoclone Herstellung von Diagnostika und Arzneimitteln GmbH
Official record identity
- Registration number
- DE0509831
- Model name
- Ak-Calibrant
- Model identifier
- 5010004
- Registration date
- September 24, 2024
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Registrant / registration holder
- ALL EIGHTS (SINGAPORE) PRIVATE LIMITED
Official description
The AK calibration set can be used for the following purposes: For direct INR determination of a patient sample (INR reference curve). For establishing laboratory, instrument and reagent specific ISI and PT normal plasma values. For constructing a reference curve in percentage of the normal.
Additional source fields
- Product owner address
- Brunner Str. 67, 1230 Vienna, Austria
- Registrant address
- 6 HARPER ROAD, #03-02, LEONG HUAT BUILDING, Singapore 369674
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.