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/2021/000489_7e3f25503d47b4000ce105548a891133_254a3f45024551d0d9b00605a7863db8. This device is marketed under the brand name Diatro Dil-DIFF. The license holder is Labtech Health Care India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Hematology Reagent-Lyse

UID: IMP/IVD/2021/000489_7e3f25503d47b4000ce105548a891133_254a3f45024551d0d9b00605a7863db8

Brand Name

Diatro Dil-DIFF

License Holder

Labtech Health Care India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diatro•Lyse-DIFF lysing reagent is a stabilized and microfiltered lysing agent for stromatolysis of erythtrocytes (Diatro Dil-DIFF), for quantitative determination of leukocytes (Diatro Dil-DIFF), leukocyte three-part differentiation (Diatro Dil-DIFF) and hemoglobin (Diatro Dil-DIFF) concentration measurement in human blood on Diatron Junior, Abacus Junior 30, Abacus Junior 5, Abacus 380, Abacus 3CT hematology analyzers. Diatro•Lyse-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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Hematology Reagent-Lyse

Brand: Diatro Cleaner

Biocant Healthcare Inc.

Hematology Reagent-Lyse - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Hematology Reagent-Lyse

Hematology Reagent-Diluent

Hematology Reagent-Cleaner

Hematology Reagent-Cleaner

Hematology Reagent-Cleaner

Hematology Reagent-Cleaner

Hematology Control

Hematology Calibrator

HbA1c Calibrator

HbA1c Reagent Kit (HbA1c Reagent Kit )

HbA1c Analyzer(HbA1c Analyzer )

HbA1c Control Material

BILIRUBIN T&D –DMSO

Sheath reagent for Spincell 5 Series(Sheath reagent for Spincell 5 Series)

CREATININE -J

Direct HbA1c

IgM (IgM )

Albumin