{ "ProductData": { "ID": "3.7.9.8.10.1", "ProductType": "Others", "BrandName": "HAMA Serum, Type I", "ProductNameAddition": "lyophilizate", "RegulatoryDisclaimer1": "For further processing only.", "DisclaimerGroup1": "", "RegulatoryDisclaimer2": "", "DisclaimerGroup2": null, "RegulatoryDisclaimer3": "", "SampleType": [ ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "HAMA Serum Type I" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/CB_IMAGE.png", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "StructureNodeStatus": "valid", "NodeName": "Interference Blocker", "NodeID": "02-0030" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "StructureNodeStatus": "valid", "NodeName": "Antibody interference blocker", "NodeID": "70-005-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "StructureNodeStatus": "valid", "NodeName": "Immunology Raw Materials", "NodeID": "02-0035" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "StructureNodeStatus": "valid", "NodeName": "Antibody interference controls", "NodeID": "70-006-00" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "StructureNodeStatus": "valid", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "180-00" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "999" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "StructureNodeStatus": "invalid", "NodeName": "", "NodeID": "99-00-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "11767275103", "MaterialDescription": "Hama-Serum1-Qual.Standard *SQ", "RegisteredProductName": "HAMA Serum, Type I", "GTIN": "", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 vial", "PackSizeDescPIM360": "reconstitution in 1 mL", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "", "OrderInformation": "Will be supplied as \"Hama-Serum I - Qual. Standard *SQ\". Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "HAMA Serum Type I is primarily intended for polyvalent and spontaneous HAMA interference occurring in healthy donors.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Will be supplied as \"Hama-Serum I - Qual. Standard *SQ\". Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "HAMA Serum Type I is a lyophilized human serum with serum ingredients within normal range. No preservative are added. The product must be handled just as carefully as patient specimens.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "HAMA serum interferences in immunoassays can vary within a broad range depending on the person's immune system.", "Country": "XG", "Code": "Background Information", "Name": "Background Information" }, { "Language": "en", "Value": "pH value (+25°C): 7-8
Protein (Biuret): ≥65 mg/vial
Dilution: Up to 1:20 recommended
Solubility: Reconstitution of lyophilizate/vial in 1 mL water results in serum typical solution
Typical concentrations determined by Roche cobas^® assays:
Alpha fetoprotein (AFP): 2.0 IU/mL
Carcinoembryonic antigen (CEA): 1.3 ng/mL
Follicle stimulating hormone (FSH): 10.0 mIU/mL
Human chorionic gonadotropin (HCG): 2.8 mIU/mL
Luteinizing hormone (LH): 8.1 mIU/mL
Prolactin: 160.7 μIU/mL
Prostate specific antigen (PSA): 0.3 ng/mL
PSA free: 0.06 ng/mL
Thyroid stimulating homone (TSH): 2.5 μIU/mL
Troponin T (TN-T): Not detectable", "Country": "XG", "Code": "Properties", "Name": "Properties" }, { "Language": "en", "Value": "Appearance: Yellowish lyophilizate
Interference effect: Corresponds to specification
Infectious parameters (determined by FDA approved methods):
Non reactive HbsAg: Corresponds to specification
Anti HIV 1+2: Negative
Anti HCV: Negative
HIV 1 NAT, non reactive: Corresponds to specification
Stability: At -15 to - 25°C within specification range for 24 months.", "Country": "XG", "Code": "Specification", "Name": "Specification" } ] } } ] }