CDSCO UID IMP/IVD/2023/000311_8f44e540340e732dc4f9176f977bd29b_7f41949e3d45fa879ab929d98be44b0b

Hemostasis analyzer-"The Yumizen G1500/G1550 instrument is an 8-channel optical coagulometer. It is suitable for the detection of clot formation, performingchromogenic and immunologic assays, in ""random access"" mode of a sample tray, using plasma specimens from sodium-citrate, anticoagulated blood samples collected into standard sample tubes, prepared as instructed. The Yumizen Gl550 instrument is equipped with a cap piercing module. The Yumizen GI500/G1550 instrument is suitable to perform a wide range of coagulometric, chromogenic and immunologic assays: Prothrombin time ActivatedPartial Thromboplastin Time Thrombin Time Fibrinogen Factor tests Antithrombin Protein C Protein S Activated Protein C D

HORIBA India Pvt. Ltd.·Device Class Class A·India CDSCO·Brand: Yumizen
Registration details
UID
IMP/IVD/2023/000311_8f44e540340e732dc4f9176f977bd29b_7f41949e3d45fa879ab929d98be44b0b
Device class
Class A
Brand name
Yumizen
Approving authority
CDSCO
Product information
Dimer Lupus Anticoagulant (Yumizen) APC resistance (Yumizen)"
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About this record

Hemostasis analyzer-"The Yumizen G1500/G1550 instrument is an 8-channel optical coagulometer. It is suitable for the detection of clot formation, performingchromogenic and immunologic assays, in ""random access"" mode of a sample tray, using plasma specimens from sodium-citrate, anticoagulated blood samples collected into standard sample tubes, prepared as instructed. The Yumizen Gl550 instrument is equipped with a cap piercing module. The Yumizen GI500/G1550 instrument is suitable to perform a wide range of coagulometric, chromogenic and immunologic assays: Prothrombin time ActivatedPartial Thromboplastin Time Thrombin Time Fibrinogen Factor tests Antithrombin Protein C Protein S Activated Protein C D is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000311_8f44e540340e732dc4f9176f977bd29b_7f41949e3d45fa879ab929d98be44b0b. This device is marketed under the brand name Yumizen. The license holder is HORIBA India Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.

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