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_408fee52a9dbe0069f425d2b6b56905e. 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_408fee52a9dbe0069f425d2b6b56905e

Brand Name

Celltac Chemi HbA1c

License Holder

Nihon Kohden India Pvt. Ltd.

Device Class

Class B

Approving Authority

Gujarat

Product Information

Hemolynac 3N 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 hemoglobin concentration

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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