{ "ProductData": { "ID": "INS_4107", "ProductType": "Instrument", "BrandName": "CoaguChek^® INRange", "ProductNameAddition": "", "RegulatoryDisclaimer1": null, "DisclaimerGroup1": null, "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "CoaguChek INRange" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/coaguchek-inrange-system-on.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "1", "StructureSystemName": "GPCH", "NodeID": "9203", "StructureNodeStatus": "Active", "NodeName": "CoaguChek INRange" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "10-000-00", "StructureNodeStatus": "Active", "NodeName": "Analyzer Instruments and Systems" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "090", "StructureNodeStatus": "Active", "NodeName": "CoaguChek" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "110-00", "StructureNodeStatus": "Active", "NodeName": "Point of Care Testing" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "100-00", "StructureNodeStatus": "Active", "NodeName": "Patient Self Testing" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "070", "StructureNodeStatus": "Active", "NodeName": "Coagulation" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "10-00-00", "StructureNodeStatus": "Active", "NodeName": "Coagulation Monitoring" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "999-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "11-00-00", "StructureNodeStatus": "Active", "NodeName": "Critical Care" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "15-00-00", "StructureNodeStatus": "Active", "NodeName": "Hematology" }, { "StructureSystemIdentifier": "Indications", "StructureSystemName": "Indications", "NodeID": "109", "StructureNodeStatus": "Active", "NodeName": "Hematology" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "635", "StructureNodeStatus": "Active", "NodeName": "CoaguChek INRange" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07404379174", "MaterialDescription": "CoaguChek INRange Japan (Bulk)", "RegisteredProductName": "CoaguChek® INRange", "GTIN": "07613336142073", "ProductCategoryText": "Meters", "OldMaterialNumber": "", "PackSizePIM360": "Not Available", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Intended Use", "Value": "The CoaguChek^® INRange system, consisting of the CoaguChek INRange meter and the CoaguChek XS^® PT Test PST test strip, is intended for the determination of prothrombin time (PT) in fresh capillary blood. It is intended for use by properly selected and appropriately trained patients and their respective caregivers.

The prothrombin time (PT) test is a general coagulation test to monitor Vitamin K Antagonist therapy.

The CoaguChek INRange system is intended for single patient self-testing only. It is not intended for use in a professional setting.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Specification", "Value": "Measuring & Sampling

Detection system	Amperometric (electrochemical) determination of the PT time after activation of the coagulation with human recombinant thromboplastin
User interface	Intuitive user interface with color display, on/off, enter, back, and up/down button
Sample application	Outside the meter top-and 2 sides: left or right,-dosing options Operating conditions

Operating conditions

Temperature	+ 15°C to + 32°C (59°F to 90°F)
Humidity	10 - 85%
Maximum altitude	4300 m (14,000 ft)
Placement	-First option: Operate the monitor on a level surface, free of vibrations -Second option: Hold the monitor in your hand, so that it is roughly horizontal
Measuring range INR	0.8 - 8.0
Interface	USB (Type B) and Bluetooth
Power	Battery - Four 1.5v AAA alkali-manganese batteries # of tests per set of batteries: Up to 60 tests or 1 year
Size	145 x 75 x 30 mm
Weight	135 g (without batteries)
Memory	400 Test Results
Auto power off	Auto off after 2 minutes of inactivity

Sample material

Sample material	Sample type: Fresh capillary whole blood
Sample size	≥ 8 μl
Interferences	Refer to the test-strip package insert

Test strips

ISI	Approx. 1.0
Sensitivity to heparin	Not at therapeutic levels, up to 0.8 I.U/ml for UFH and to 2 anti-Xa U/ml for LMWH
Quality control	On each strip, through the same channel as the blood passes
Stability	21 months from production (+ 2°C to + 30°C)

Display

Display	Color Display of target range

", "Language": "en", "Country": "XG", "Code": "Specification" }, { "Name": "Product Purpose", "Value": "The CoaguChek^® INRange system, consisting of the CoaguChek INRange meter and the CoaguChek XS^® PT Test PST test strip, is intended for the determination of prothrombin time (PT) in fresh capillary blood. It is intended for use by properly selected and appropriately trained patients and their respective caregivers.

The prothrombin time (PT) test is a general coagulation test to monitor Vitamin K Antagonist therapy.

The CoaguChek INRange system is intended for single patient self-testing only. It is not intended for use in a professional setting.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }