T/CHBAS 21-2022 Active Group standards

T/CHBAS 21-2022 Production Technical Regulations for Difloxacin Biobarcode Detection Reagent Kit

Publish Date: 2022-06-06 Implement Date: 2022-06-07 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CHBAS 21-2022

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Medical materials

Publish Date: 2022-06-06

Implement Date: 2022-06-07

Scope

Scope: This document establishes the main components, production process, evaluation methods, user manual, and labels of the Difloxacin BioBarcode Detection Kit. This document is applicable to the production of Difloxacin BioBarcode Detection Kits based on microwell plate silver staining. Main technical content: 6 Evaluation methods for technical indicators 6.1.1 The kit is divided into qualitative detection kits and quantitative detection kits. The detection report issued by the qualitative detection kit only provides a judgment of negative or positive results, and the specific detection values are not reported. The detection report issued by the quantitative detection kit reports the detection values above the quantitative limit. 6.1.2 The qualitative detection kit needs to evaluate the sensitivity, specificity, false negative rate/false positive rate of the kit. The quantitative detection kit T/CHBAS 21—20224 needs to evaluate the linearity and range, detection limit, quantitative limit, accuracy, and precision of the kit.