Stromatolyser - 4DL - India CDSCO Medical Device Registration

Stromatolyser - 4DL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000113_7c04183c10fed7660086802f6a9c3afd_0d0a1674a72fb0aa99eab9fc8577e410. 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 - 4DL

UID: MFG/IVD/2020/000113_7c04183c10fed7660086802f6a9c3afd_0d0a1674a72fb0aa99eab9fc8577e410

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-4DL is a reagent that lyses RBC for determination of 4-part differential count or 5-part differential count* and WBC count with Sysmex automated hematology analyzers (Stromatolyser - WH)