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HSA · registration DE0508470

Siemens Dade PFA Collagen/ EPI and Dade PFA Collagen/ ADP Test Cartridges

SingaporeHematologyClass BSiemens Healthcare Diagnostics Products GmbH
Official record identity
Registration number
DE0508470
Model name
INNOVANCE PFA-200 System; Dade PFA Collagen/EPI Test Cartridge; Dade PFA Collagen/ADP Test Cartridge; Dade PFA Trigger Solution; PFA Cassettes; PFA Cleaning Pads; Dade PFA Priming Cartridges; Dade PFA Vacuum Cups; PFA O-Ring Service Tool; PFA O-Rings
Model identifier
B4170-100; B4170-20; B4170-21; B4170-50; B4170-70; B4170-73; B4170-74; B4170-75; B4170-77; B4170-78
Registration date
September 11, 2023
Source update date
April 09, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
Hematology
Published parties
Registrant / registration holder
SYSMEX ASIA PACIFIC PTE. LTD.
Official description

Dade PFA Collagen/ EPI Test Cartridge and Dade PFA Collagen/ ADP Test Cartridge are in vitro diagnostic reagents for the quantitative determination of the collagen/epinephrine- and collagen/ADP-induced PFA closure times. The assays can be used as aid to diagnosis and follow up of congenital, acquired or therapy induced defects of primary hemostasis, including von Willebrand factor (vWF) dependent deficiencies, in patients at risk for or suspected of impaired primary hemostasis. The assays are performed using human sodium citrated whole blood by means of an automated, platelet adhesion and aggregation method under flow conditions.

Additional source fields
Product owner address
Emil-von-Behring-Str. 76, 35041 Marburg, Germany, Germany
Registrant address
9 TAMPINES GRANDE, #06-18, ASIA GREEN, Singapore 528735
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.