{
"ProductData": {
"ID": "RTD000826",
"ProductType": "Others",
"BrandName": "Diastase Kit",
"ProductNameAddition": "",
"RegulatoryDisclaimer1": "For in vitro diagnostic use.",
"DisclaimerGroup1": "IVD",
"RegulatoryDisclaimer2": null,
"DisclaimerGroup2": null,
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],
"LicenseDisclaimers": [
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"Clone": "",
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""
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""
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"MaterialDescription": "DIASTASE KIT",
"RegisteredProductName": "Diastase Kit",
"GTIN": "04015630971381",
"ProductCategoryText": "Reagents, kits",
"OldMaterialNumber": "860-004",
"PackSizePIM360": "75 tests",
"PackSizeDescPIM360": "Not Available",
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"ReadyForUse": "true",
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}
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"ProductSpec": [
{
"ProductSpecVariant": {
"Chapters": [
{
"Name": "Storage Conditions (Product)",
"Value": "The Diastase Kit should be stored at 2-8°C.",
"Language": "en",
"Country": "XG",
"Code": "Storage Conditions (Product)"
},
{
"Name": "Content",
"Value": "The reagent vials are supplied in barcode labeled carriers to insert into the reagent tray of the instrument. Each kit contains sufficient reagent for 75 tests:
One 22 mL vial of Diastase contains approximately 1.2 - 5% diastase of malt, with sodium azide as a preservative.
One vial insert with sipping straw.",
"Language": "en",
"Country": "XG",
"Code": "Content"
},
{
"Name": "Intended Use",
"Value": "Diastase Kit, in conjunction with PAS Staining Kit (860-014 / 05279291001), is intended for use as a digestion reagent to aid in the determination of glycogen in formalin-fixed, paraffin-embedded tissue.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
This product is intended for in vitro diagnostic (IVD) use.",
"Language": "en",
"Country": "XG",
"Code": "Intended Use"
},
{
"Name": "Background Information",
"Value": "Diastase Kit is a single bottle kit used in conjunction with the PAS Staining Kit. The PAS Staining Kit is a modification of a technique originally described by McManus in 1946 to visualize mucins, glycogen, basement membrane and fungal organisms through the combination of oxidation of polysaccharides by periodic acid and staining with the Schiff’s reagent.1
In practice, two sections of the same tissue sample are stained with the PAS Staining Kit: one of them is treated with Diastase in advance, which results in two PAS-stained sections, one with and one without glycogen, that are then compared side-by-side to determine the presence and distribution of glycogen in the sample.
1. Layton C, Bancroft JD. Bancroft’s Theory and Practice of Histological Techniques.In: Elsevier; 2019. Accessed 02/15/2021.",
"Language": "en",
"Country": "XG",
"Code": "Background Information"
},
{
"Name": "Principle",
"Value": "Diastase digests the glycogen present in the tissue so it is washed out of the tissue before PAS staining occurs. Diastase digestion is used to differentially determine if the PAS positive component is glycogen. The PAS Staining Kit uses Periodic Acid reagent to oxidize glycols to aldehydes. The Schiff’s Reagent reacts with aldehydes to form a colorless dialdehyde compound that is transformed to the magenta staining of glycol containing cellular components.2
This kit is optimized for use on BenchMark Special Stains instruments. The reagents are applied to tissue on microscope slides and mixed over the entire specimen.
2. Carson F, Hladik C. Histotechnology: A Self Instructional Text, 3rd edition. Hong Kong: American Society for Clinical Pathology Press; 2009.",
"Language": "en",
"Country": "XG",
"Code": "Principle"
},
{
"Name": "Product Purpose",
"Value": "Diastase Kit, in conjunction with PAS Staining Kit (860-014 / 05279291001), is intended for use as a digestion reagent to aid in the determination of glycogen in formalin-fixed, paraffin-embedded tissue.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
This product is intended for in vitro diagnostic (IVD) use.",
"Language": "en",
"Country": "XG",
"Code": "Product Purpose"
}
]
}
}
]
}
