HSA · registration DE0017119VITROS Chemistry Products ACET Slides
SingaporeClinical chemistryClass BOrtho-Clinical Diagnostic Inc
Official record identity
- Registration number
- DE0017119
- Model name
- VITROS Chemistry Products ACET Slides (Acetaminophen- Paracetamol); VITROS Chemistry Products TDM Performance Verifier II; VITROS Chemistry Products FS Diluent Pack 3; VITROS Chemistry Products MicroSensor Fluids I & II; VITROS Chemistry Products Specialty Diluent; VITROS Chemistry Products Calibrator Kit 9; Chemistry Products TDM Performance Verifier I
- Model identifier
- 1037274; 1792357; 6801754; 6801755; 8559825; 8568040; 8962540
- Registration date
- May 11, 2015
- Source update date
- April 16, 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 Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) 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.