This Standard specifies the terms and definitions, designation, classification and composition, requirements, test methods, mark, label and use instructions, package, transportation and storage of α/β-thalassemia gene typing detection kit (hereinafter referred to as “kit”). This Standard is applicable to the detection kit for detecting peripheral whole blood samples and pregnant amniotic fluid samples; the adopted technical methods include real-time PCR fluorescent method, PCR-reverse dot hybridization method, fluorescent PCR melting curve method, gene chip method, and gap PCR (gap-PCR) method, etc.
Basic Data
Standard ID
YY/T 1527-2017 (YY/T1527-2017)
Description (Translated English)
��/��-Thalassemia gene typing detection kit
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
6,647
Date of Issue
2017-03-28
Date of Implementation
2018-04-01
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 38
