{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For further processing only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "HAMA Serum Type II", "DisclaimerGroup1": "Other - Non IVD", "ControlTissue": [ "" ], "BrandName": "HAMA Serum, Type II", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.7.9.8.10.2", "ProductNameAddition": "lyophilizate", "Species": [ "" ], "Clone": "" }, "ProductSpec": { "ProductSpecVariant": { "Chapters": [ { "Language": "English", "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): 3.5 IU/mL
Carcinoembryonic antigen (CEA): 1.2 ng/mL
Follicle stimulating hormone (FSH): 7.0 mIU/mL
Human chorionic gonadotropin (HCG): 3.0 mIU/mL
Luteinizing hormone (LH): 6.7 mIU/mL
Prolactin: 114 μIU/mL
Prostate specific antigen (PSA): 0.3 ng/mL
PSA free: 0.05 ng/mL
Thyroid stimulating homone (TSH): 1.6 μIU/mL
Troponin T (TN-T): 0.01 ng/mL", "Name": "CB - Properties" }, { "Language": "English", "Value": "Appearance: Yellowish lyophilizate
Interference effect: Corresponds to specification
Infectious parameters:
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.", "Name": "CB - Specification" }, { "Language": "English", "Value": "Will be supplied as \"HAMA Serum 2L *SQ\". Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "English", "Value": "HAMA Serum Type II primarily represents mono-/bivalent and specific HAMA interference occurring after treatment with monoclonal antibodies.", "Name": "Applications" }, { "Language": "English", "Value": "HAMA Serum Type II 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.", "Name": "Product Description" }, { "Language": "English", "Value": "HAMA serum interferences in immunoassays can vary within a broad range depending on the person's immune system.", "Name": "Background Information" }, { "Language": "English", "Value": "Appearance: Yellowish lyophilizate
Interference effect: Corresponds to specification
Infectious parameters:
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.", "Name": "Specification" }, { "Language": "English", "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): 3.5 IU/mL
Carcinoembryonic antigen (CEA): 1.2 ng/mL
Follicle stimulating hormone (FSH): 7.0 mIU/mL
Human chorionic gonadotropin (HCG): 3.0 mIU/mL
Luteinizing hormone (LH): 6.7 mIU/mL
Prolactin: 114 μIU/mL
Prostate specific antigen (PSA): 0.3 ng/mL
PSA free: 0.05 ng/mL
Thyroid stimulating homone (TSH): 1.6 μIU/mL
Troponin T (TN-T): 0.01 ng/mL", "Name": "Properties" } ] } }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "StructureSystemID": null, "NodeID": "520" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Interference Blocker", "StructureSystemID": null, "NodeID": "02-0030" }, { "StructureSystemName": "OWP Product Types", "NodeName": "Raw Materials and Reagents->Antibody interference blocker", "StructureSystemID": null, "NodeID": "70-005-00" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Immunology Raw Materials", "StructureSystemID": null, "NodeID": "02-0035" }, { "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureSystemID": null, "NodeID": "01-01-01-07-00" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "05167060103", "MaterialDescription": "HAMA Serum 2L *SQ", "RegisteredProductName": "", "GTIN": "07613336131848", "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 2L *SQ\". Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ ] } }