Lyse Reagents - India CDSCO Medical Device Registration

Lyse Reagents is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000059_58863dca47d28852476d9296348a5a3c_082b28f6ed7fde0a1f003acb5746d36a. This device is marketed under the brand name Celltac Chemi HbA1c . The license holder is Nihon Kohden India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Gujarat.

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CDSCO Registered

Class Class B

Lyse Reagents

UID: MFG/IVD/2022/000059_58863dca47d28852476d9296348a5a3c_082b28f6ed7fde0a1f003acb5746d36a

Brand Name

Celltac Chemi HbA1c

License Holder

Nihon Kohden India Pvt. Ltd.

Device Class

Class B

Approving Authority

Gujarat

Product Information

Hemolynac･5 is for in vitro diagnostic use as a lysing reagent for use in lysing red blood cells in diluted human venous whole blood samples for analysis by Nihon Kohden hematology analyzers to measure the five differential white blood cells

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C-Reactive Protein Kit

Brand: Celltac Chemi HbA1c

Nihon Kohden India Pvt. Ltd.

Lyse Reagents - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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C-Reactive Protein Kit

Cleaner Reagent

Cleaner Reagent

Cleaner Reagent

Diluent

HbA1c kit

Lyse Reagents

Lyse Reagents

Lyse Reagents

Rinse Solution

C-Reactive Protein Kit

Cleaner Reagent

Cleaner Reagent

Cleaner Reagent

Diluent

HbA1c kit

Lyse Reagents

Lyse Reagents

Lyse Reagents

Rinse Solution