Stromatolyser - WH - India CDSCO Medical Device Registration

Stromatolyser - WH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000113_7a60ae80c2171daaa0d15aaa1bd2c6ad_a9465f8dd2cfc4a3bbd4a6f4bce64a7d. This device is marketed under the brand name Stromatolyser - WH. The license holder is Sysmex India Private Limited, and it is classified as Device Class Class B. The approving authority is Solan(BBN).

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CDSCO Registered

Class Class B

Stromatolyser - WH

UID: MFG/IVD/2020/000113_7a60ae80c2171daaa0d15aaa1bd2c6ad_a9465f8dd2cfc4a3bbd4a6f4bce64a7d

Brand Name

Stromatolyser - WH

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

Solan(BBN)

Product Information

For in vitro diagnostic use only. STROMATOLYSER-WH is a reagent that lyses RBC for accurate WBC count determination, WBC tri-modal size distribution analysis and hemoglobin level measurement. The reagent is colorless transparent and contains no cyanide or azide compound. It is intended for use in conjunction with selected Sysmex automated hematology analyzers