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Ultimate -D Bilirubin Control LEVEL 2 - India CDSCO Medical Device Registration

Ultimate -D Bilirubin Control LEVEL 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000032_fc0af42003ccf96c3a4ce6868cbb0c56_d46502bd22de04d56dd94a7596d70178. 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
Ultimate -D Bilirubin Control LEVEL 2
UID: IMP/IVD/2019/000032_fc0af42003ccf96c3a4ce6868cbb0c56_d46502bd22de04d56dd94a7596d70178

Brand Name

ApoA 2 x 100

Device Class

Class B

Approving Authority

CDSCO

Product Information

Ultimate-D Bilirubin Liquid Controls are stabilized and designed for use in the quality control of total and direct-acting (ApoA 2 x 100) bilirubin determinations by manual and automated analytical systems. Multiple levels are available separately to provide control across the range of linearity or at specific levels

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