Automated Hematology Analyzer - India CDSCO Medical Device Registration

Automated Hematology Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000202_f2d89d813ffa682689812ef1d978326a_e802c89f7a851fbf280548bfe66c6bbf. This device is marketed under the brand name Alere h S30. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Automated Hematology Analyzer

UID: IMP/IVD/2023/000202_f2d89d813ffa682689812ef1d978326a_e802c89f7a851fbf280548bfe66c6bbf

Brand Name

Alere h S30

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Alere h S30 uses Coulter electrical impedance and colorimetry methods to test the parameters of WBC, RBC, PLT and HGB, does three differentials of WBC and provides the histogram information.