Swelab Alfa Diluent, RFID - India CDSCO Medical Device Registration

Swelab Alfa Diluent, RFID is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000169_5467c59ac0cd6fdd3c3797bfced544b2_6f4bf23604a8f4fdbb4ae64530be7777. This device is marketed under the brand name Boule. The license holder is Science House Medicals Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Swelab Alfa Diluent, RFID

UID: IMP/IVD/2022/000169_5467c59ac0cd6fdd3c3797bfced544b2_6f4bf23604a8f4fdbb4ae64530be7777

Brand Name

Boule

License Holder

Science House Medicals Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Swelab Alfa Diluent RFID is a hematology diluent used for cell counting and sizing in the Swelab Alfa Series automated, hematology analyzers/instruments

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Con-Diff Low

Brand: Boule

Science House Medicals Private Limited

Swelab Alfa Diluent, RFID - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Con-Diff Low

Calibrator

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Con-Diff Normal

Swelab Alfa Lyse, RFID

Control Diff Low

Control Diff High

Control Diff Normal

Cal

Control Diff Tri-level

Controls(EDAN Controls )

Calibrant Fluid Pack(EDAN Calibrant Fluid Pack )

Test Cartridge(EDAN Test Cartridge )

Test Cartridge(EDAN Test Cartridge )

Con-Diff Low

Calibrator

Con-Diff High

Con-Diff Normal

Swelab Alfa Lyse, RFID