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Synchron Control Multilevel Comprehensive Chemistry Control Serum - India CDSCO Medical Device Registration

Synchron Control Multilevel Comprehensive Chemistry Control Serum is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000032_f884a5a0a16078173427fd3835a612c0_a88e02caba92e7e07a5a771027f8a9dd. This device is marketed under the brand name ApoA 2 x 100. The license holder is Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Synchron Control Multilevel Comprehensive Chemistry Control Serum
UID: IMP/IVD/2019/000032_f884a5a0a16078173427fd3835a612c0_a88e02caba92e7e07a5a771027f8a9dd

Brand Name

ApoA 2 x 100

Device Class

Class B

Approving Authority

CDSCO

Product Information

SYNCHRON Controls are made from stabilized human serum and are designed to monitor the performance of SYNCHRON Systems in the clinical laboratory. SYNCHRON Control Levels 1, 2, and 3 bear a quantitative relationship to one another; Level 2 is manufactured by combining equal quantities of Levels 1 and 3. The use of three levels enables the laboratorian to monitor changes in calibration and linearity along with analytical error and imprecision

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