HSA · registration DE0017126VITROS Chemistry Products dLDL Reagent
SingaporeClinical chemistryClass BOrtho-Clinical Diagnostic Inc
Official record identity
- Registration number
- DE0017126
- Model name
- VITROS Chemistry Products Calibrator Kit 19; VITROS Chemistry Products dLDL Reagent; VITROS Chemistry Products FS Diluent Pack 2; VITROS Chemistry Products MicroSensor Fluids I & II; VITROS Chemistry Products FS Calibrator 1; Chemistry Products Performance Verifier I; VITROS Chemistry Products Performance Verifier II
- Model identifier
- 6801703; 6801728; 6801753; 6801755; 6801873; 8067324; 8231474
- Registration date
- May 11, 2015
- Source update date
- December 04, 2018
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Ortho-Clinical Diagnostic Inc
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Official description
VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.
Additional source fields
- Product owner address
- 100 Indigo Creek Drive, Rochester, New York, 14626, New York, United States
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
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.