Sheath Fluid - India CDSCO Medical Device Registration

Sheath Fluid is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000040_4cbee8a38bf9dbb423c3804a9cfc07ab_2145367e7861ae46e7e7d9f2263bfd62. This device is marketed under the brand name U2600 Series. The license holder is BIODX HEALTHCARE, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Sheath Fluid

UID: IMP/IVD/2020/000040_4cbee8a38bf9dbb423c3804a9cfc07ab_2145367e7861ae46e7e7d9f2263bfd62

Brand Name

U2600 Series

License Holder

BIODX HEALTHCARE

Device Class

Class A

Approving Authority

CDSCO

Product Information

The product is used for diluting urine samples to form sheath flow, which is conducive to cell counting and classification by analytical instruments. It should be used by healthcare professionals and properly trained personnel

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MedTech Regulatory Expert

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