Alfa Lyse - India CDSCO Medical Device Registration
Alfa Lyse is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000019_fd6223ac2f5a98368e6b019e2804e847_038d05c926ec8dfba4b40f1acb692208. This device is marketed under the brand name Boule. The license holder is AAMX BIOMEDICALS, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Boule
License Holder
AAMX BIOMEDICALSDevice Class
Approving Authority
CDSCO
Product Information
used in IN-VITRO Diagnostics
Con-Diff Low
Brand: Boule
Science House Medicals Private Limited
Calibrator
Brand: Boule
Science House Medicals Private Limited
Con-Diff High
Brand: Boule
Science House Medicals Private Limited
Con-Diff Normal
Brand: Boule
Science House Medicals Private Limited
Swelab Alfa Diluent, RFID
Brand: Boule
Science House Medicals Private Limited
Swelab Alfa Lyse, RFID
Brand: Boule
Science House Medicals Private Limited
Alfa Lyse
Brand: Swelab
POCT Services Private Limited
Alfa Lyse
Brand: Medonic
LAB X
Control Diff Low
Brand: Boule
POCT Services Private Limited
Control Diff High
Brand: Boule
POCT Services Private Limited
CALIBRATOR
Brand: BOULE
Control Diff Low
Brand: BOULE
Control Diff High
Brand: BOULE
Control Diff Normal
Brand: BOULE
Control Diff Trilevel
Brand: BOULE
Alfa Diluent with RFID
Brand: Boule
Cleaning Kit
Brand: Boule
Alfa Diluent
Brand: Boule
Lumi- L2 Lyse
Brand: Boule
Alfa Lyse with RFID
Brand: Boule