CDSCO UID MFG/IVD/2022/000029_d93b044a8a2412045809545c877639e2_8a7666ff0570f13e03e68f6c9d46b586

Hemoglobin Control Level I & II For use on Hemoglobin Meter

CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class A·India CDSCO·Brand: HbChek Control Set
Registration details
UID
MFG/IVD/2022/000029_d93b044a8a2412045809545c877639e2_8a7666ff0570f13e03e68f6c9d46b586
Device class
Class A
Brand name
HbChek Control Set
Approving authority
Goa
Product information
HbChek Hemoglobin Meter is an invasive blood haemoglobin measuring system. This device can be used in hospitals or clinics for blood measurement. The device can be used by professional and there is no need for only trained professionals. This device also saves the time and efforts put during a blood test in any pathological lab. The HBChek Control Set are assayed quality controls which are used to verify the performance of the HBChek Hemoglobin Meter. The Hemoglobin Controls are quality control material having a known hemoglobin concentration in two relevant ranges. The Hemoglobin controls are used on the Hemoglobin Meter like a patient sample, they provide proof of proper functioning of the HbChek Hemoglobin Meter. Accurately testing known levels of hemoglobin ensures that the testing system and the technique used in testing gives accurate results on patient tests
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About this record

Hemoglobin Control Level I & II For use on Hemoglobin Meter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000029_d93b044a8a2412045809545c877639e2_8a7666ff0570f13e03e68f6c9d46b586. This device is marketed under the brand name HbChek Control Set. The license holder is CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class A. The approving authority is Goa.

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