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Items and information required for blood glucose test strip product registration


1. All inspection equipment includes but is not limited to pipette guns, balances, biochemical analyzer measurement certificates and the certificates are within the validity period;
2. Standard substance certificate (glucose standard, uric acid standard, etc.) with company seal
3. Standard substance configuration method and configuration record;
3. Product technical requirements (including traceability documents and certificates of instruments and test strips);
4. Prepare the samples according to the minimum amount required in the technical requirements (glycemic gold test strips, blood ketone gold test strips, uric acid carbon test strips, glucose quality control solution, two three-in-one instruments);
5. Test strips, quality control solutions, small box packaging, bottle stickers, test strip barrels, reagent bottles, etc .;
6. Chemical raw materials and reagents (500g each of citric acid, sodium citrate, absolute ethanol, sodium hydroxide, and anhydrous glucose; uric acid standard substance (5g), glucose standard substance (2g), 3-hydroxybutyric acid (5g) , Glucose kit, uric acid kit, β-hydroxybutyric acid kit each with more than one box, and the shelf life);
7. Product inspection application letter;

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