{
"ProductData": {
"RelatedLinks": "",
"RegulatoryDisclaimer1": "For in vitro diagnostic use.",
"RegulatoryDisclaimer2": "",
"StainLocalization": [
""
],
"ProductType": "Instrument",
"DisclaimerGroup2": null,
"ProductNameGlobal": "cobas p 480",
"DisclaimerGroup1": "IVD",
"ControlTissue": [
""
],
"BrandName": "
cobas p 480 instrument",
"LicenseDisclaimers": [
],
"Isotypes": "",
"RegulatoryDisclaimer3": "",
"ID": "INS_4091",
"ProductNameAddition": "",
"Species": [
""
],
"Clone": ""
},
"ProductImageDetails": {
"ImagePath": "https://pim-media.roche.com/Images/qcobas p 480.jpg",
"ImageType": "Image main"
},
"Product2Taxomony": {
"Product2TaxomonyReferences": [
{
"StructureSystemIdentifier": "1",
"StructureSystemName": "GPCH",
"NodeName": null,
"NodeID": null
},
{
"StructureSystemIdentifier": "OWP_Organization",
"StructureSystemName": "Organization",
"NodeName": null,
"NodeID": null
},
{
"StructureSystemIdentifier": "OWP_Product_Solutions",
"StructureSystemName": "OWP Product Solutions",
"NodeName": null,
"NodeID": null
},
{
"StructureSystemIdentifier": "OWP_Family",
"StructureSystemName": "Product Families",
"NodeName": null,
"NodeID": null
},
{
"StructureSystemIdentifier": "OWP_Product_Types",
"StructureSystemName": "Product Types",
"NodeName": null,
"NodeID": null
},
{
"StructureSystemIdentifier": "Lab_Type",
"StructureSystemName": "Lab Types",
"NodeName": null,
"NodeID": null
},
{
"StructureSystemIdentifier": "Product_Solutions",
"StructureSystemName": "Product Solutions",
"NodeName": null,
"NodeID": null
}
]
},
"Product2Materials": {
"P2MaterialReferences": [
{
"MaterialNum": "06765629001",
"MaterialDescription": "cobas p 480",
"RegisteredProductName": "",
"GTIN": "04015630935680",
"ProductCategoryText": "Instruments",
"OldMaterialNumber": "",
"PackSizePIM360": "",
"PackSizeDescPIM360": "",
"MaterialAnnotation": "",
"ReadyForUse": "",
"OrderInformation": ""
}
]
},
"Product2Products": {
"Product2ProductReference": [
{
"ProductID": "RMD-4800-CDIFF-001",
"BrandName": "
cobas® Cdiff Test",
"ProductNameAddition": "for use on the
cobas® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-CMV-001",
"BrandName": "
cobas® CMV Test",
"ProductNameAddition": "Quantitative nucleic acid test for use on the
cobas® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-CTNG-005",
"BrandName": "
cobas® 4800 CT/NG Test",
"ProductNameAddition": "",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-EGFRV2-003",
"BrandName": "
cobas® EGFR Mutation Test v2",
"ProductNameAddition": "",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-F2F5-001",
"BrandName": "
cobas® Factor II and Factor V Test",
"ProductNameAddition": "",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-HBV-001",
"BrandName": "
cobas® HBV",
"ProductNameAddition": "Quantitative nucleic acid test for use on the
cobas® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-HCV-001",
"BrandName": "
cobas® HCV",
"ProductNameAddition": "Quantitative nucleic acid test for use on the
cobas® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-HCVGT-001",
"BrandName": "
cobas® HCV GT",
"ProductNameAddition": "HCV genotyping test for use on the
cobas® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-HIV1-001",
"BrandName": "
cobas® HIV-1 Test",
"ProductNameAddition": "Quantitative nucleic acid test for use on the
cobas® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-HPV-001",
"BrandName": "
cobas® 4800 HPV Amplification/Detection Kit",
"ProductNameAddition": "",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-HSV-001",
"BrandName": "
cobas® HSV 1 and 2 Test",
"ProductNameAddition": "for use on the cobas
® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-KRAS-001",
"BrandName": "
cobas® KRAS Mutation Test",
"ProductNameAddition": "",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-LSR-001",
"BrandName": "BRAF/NRAS Mutation Test (LSR)",
"ProductNameAddition": "The test detects a total of 36 mutations. Eleven mutations are detected in exons 11 and 15 of the BRAF gene and twenty-five mutations are detected in exons 2, 3 and 4 of the NRAS gene. these mutations are detected and reported in a total of 3 master mixes:
MMx 1: channel 1: BRAF V600E/E2/D
BRAF V600K*
channel 2: NRAS G12
channel 3: BRAF Exon 11
channel 4: BRAF Internal Control (exon 17)
MMx 2: channel 1: BRAF V600R
BRAF V600K*
channel 2: NRAS Q61
channel 3: NRAS A18T
channel 4: NRAS Internal Control (exon 5)
*BRAF V600K: In order for this mutation to be reported, both MMx 1 and MMx2 must generate a positive signal in channel 1
MMx 3: channel 1: BRAF K601E
channel 2: NRAS G13X
channel 3: NRAS Other Exon 3/4
channel 4: NRAS Internal Control (exon 5)
For more specific information on which specific mutation are included in each channel and Master Mix, please consult the Instructions for Use (available in the \"download\" section)
",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-LSR-002",
"BrandName": "KRAS Mutation Test v2 (LSR)",
"ProductNameAddition": "The test detects a total of 28 mutations in exons 2, 3 and 4 of the KRAS gene. These mutations are detected and reported in a total of 3 master mixes:
MMx 1:
- channel 1: G12 A/D/R/S/V
- channel 2: Q61 E/Hc/Hat/K/L/P/R
- channel 3: none
- channel 4: KRAS Internal Control
MMx 2:
- channel 1: G13 A/C/D/R/S/V
- channel 2: K117 Nc/Nt
- channel 3: A59 E/G/S/Tc
- channel 4: KRAS Internal Control
MMx 3:
- channel 1: G12C
- channel 2: A146 P/T/V
- channel 3: Q61Hc
- channel 4: KRAS Internal Control
The IC for KRAS covers a region of the 3' UTR that is reported to be absent of somatic mutations
Result reporting for channels that detect more than one mutation will not identify each specific mutation. For example, a G12R mutation will be reported as G12X.
For more specific information on which specific mutation are included in each channel and Master Mix, please consult the Instructions for Use (available in the \"download\" section)",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-MRSASA-001",
"BrandName": "
cobas® MRSA/SA Test",
"ProductNameAddition": "for use on the
cobas® 4800 System",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-MRSASA-002",
"BrandName": "
cobas® 4800 MRSA/SA Controls and Cofactor Kit",
"ProductNameAddition": "",
"ReferenceType": "Reagent"
},
{
"ProductID": "RMD-4800-PIK3CA-001",
"BrandName": "
cobas® PIK3CA Mutation Test",
"ProductNameAddition": "",
"ReferenceType": "Reagent"
}
]
},
"ProductSpec": [
{
"ProductSpecVariant": {
"Chapters": [
{
"Language": "en",
"Value": "The
cobas p 480 instrument is a stand-alone general purpose laboratory instrument to minimize repetitive manual tasks associated with specimen handling. This instrument is intended to perform pre-analytics processing such as decapping and recapping, pipetteand spin-mixing specimens, and aliquoting specimens to secondary vials. Additional hardware components and programing flexibility allow automation of more complex pre-analytic processes including reagent addition and heating.",
"Name": "Intended Use"
}
]
}
}
]
}