HSA · registration DE0017121VITROS Chemistry Products ALB Slides
SingaporeClinical chemistryClass BOrtho-Clinical Diagnostic Inc
Official record identity
- Registration number
- DE0017121
- Model name
- VITROS Chemistry Products Calibrator Kit 4; VITROS Chemistry Products ALB Slides (Albumin); VITROS Chemistry Products MicroSensor Fluids I & II; Chemistry Products Performance Verifier I; VITROS Chemistry Products ALB Slides (Albumin); VITROS Chemistry Products Performance Verifier II
- Model identifier
- 1204668; 1988211; 6801755; 8067324; 8196057; 8231474
- Registration date
- May 11, 2015
- Source update date
- July 07, 2020
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 ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
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.