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) - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

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

Brand Name

Access Intact PTH

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

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

Class B

Access Total BhCG (Access Total BhCG )

Brand: Access Intact PTH

Beckman Coulter India Private Limited

Class B

Brand: CellaVision DM9600

Class A