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Blood Hemoglobin Measuring Test Strips - India CDSCO Medical Device Registration

Blood Hemoglobin Measuring Test Strips is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000046_d2237f9db0edc6312294d293a07ecf28_29bfba6a01f1ff1ede65f58a29a6ce10. This device is marketed under the brand name 10 strips per pack, 25 strips per pack, 50 strips per pack. The license holder is Sensa Core Medical Instrumentation Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Telangana.

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CDSCO Registered
Class Class B
Blood Hemoglobin Measuring Test Strips
UID: MFG/IVD/2019/000046_d2237f9db0edc6312294d293a07ecf28_29bfba6a01f1ff1ede65f58a29a6ce10

Brand Name

10 strips per pack, 25 strips per pack, 50 strips per pack

Device Class

Class B

Approving Authority

Telangana

Product Information

Sensa Core's Hemo Spark Test strips are firm plastic strips onto which a multi layer dry reagent is affixed and are intended to be read on the Hemo Spark meter. The Test strips function by lysing erythrocytes and converting the released hemoglobin into methemoglobin. This test is for the quantitative determination of Hemoglobin (10 strips per pack, 25 strips per pack, 50 strips per pack) and calculated hematocrit (10 strips per pack, 25 strips per pack, 50 strips per pack) in capillary and venous whole blood by using Reflectance Photometry Principle.

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