Access 25 Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay System(Access 25 Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay System)
- UID
- IMP/IVD/2019/000053_df12074eb0b9bd7da1162a728f842707_9eca2b69916c8fe98a0d21d1d74d523e
- Device class
- Class B
- Brand name
- Access Intact PTH
- License holder
- Beckman Coulter India Private Limited
- Approving authority
- CDSCO
- Product information
- The Access 25(Access Intact PTH) Vitamin D Total Calibrators are intended to calibrate the Access 25(Access Intact PTH) Vitamin D Total assay for the quantitative determination of total 25-hydroxyvitamin D [25(Access Intact PTH)D] levels in human serum and plasma using the UniCel DxI 800 Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency. † UniCel DxI 600, UniCel DxI 800, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i
Access 25 Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay System(Access 25 Vitamin D Total Calibrators for use on the UniCel DxI Immunoassay System) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000053_df12074eb0b9bd7da1162a728f842707_9eca2b69916c8fe98a0d21d1d74d523e. This device is marketed under the brand name Access Intact PTH. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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