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"MaterialDescription": "HAMA Serum 2L *SQ",
"RegisteredProductName": "HAMA Serum, Type II",
"GTIN": "07613336131848",
"ProductCategoryText": "Reagents, kits",
"OldMaterialNumber": "",
"PackSizePIM360": "1 vial",
"PackSizeDescPIM360": "reconstitution in 1 mL",
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"Value": "Will be supplied as \"HAMA Serum 2L *SQ\". Unit of measure is \"piece\".",
"Country": "XG",
"Code": "CB - Order Information",
"Name": "CB - Order Information"
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"Value": "HAMA Serum Type II primarily represents mono-/bivalent and specific HAMA interference occurring after treatment with monoclonal antibodies.",
"Country": "XG",
"Code": "Applications",
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"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.",
"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"
},
{
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"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.",
"Country": "XG",
"Code": "Specification",
"Name": "Specification"
},
{
"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): 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",
"Country": "XG",
"Code": "Properties",
"Name": "Properties"
}
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}
]
}