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Hematology Reagent-Lyse - India CDSCO Medical Device Registration

Hematology Reagent-Lyse is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000062_7e3f25503d47b4000ce105548a891133_9f2aacff7875ac6416f729715154b0ae. This device is marketed under the brand name Diatro Cleaner. The license holder is Biocant Healthcare Inc., and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class B
Hematology Reagent-Lyse
UID: IMP/IVD/2022/000062_7e3f25503d47b4000ce105548a891133_9f2aacff7875ac6416f729715154b0ae

Brand Name

Diatro Cleaner

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diatroโ€ขLyse-DIFF lysing reagent is a stabilized and microfiltered lysing agent for stromatolysis of erythtrocytes (Diatro Cleaner), for quantitative determination of leukocytes (Diatro Cleaner), leukocyte three-part differentiation (Diatro Cleaner) and hemoglobin (Diatro Cleaner) concentration measurement in human blood on Diatron Junior, Abacus Junior 30, Abacus Junior 5, Abacus 380, Abacus 3CT hematology analyzers. Diatroโ€ขLyse-DIFF lysing reagent should be used with only Diatron reagents. Erroneous results may be obtained if the reagent is applied with third party reagents

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