YY/T 1160-2009 Translated English of Chinese Standard. (YYT 1160-2009, YY/T1160-2009, YYT1160-2009): Carcinoembryonic Antigen Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)https://www.chinesestandard.net, 2015. 2. 5. - 13ÆäÀÌÁö This Standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, marks, labels, operating instructions, packaging, transportation, and storage of carcinoembryonic antigen (CEA) quantitative determination reagent (kit) (chemiluminescent immunoassay). |
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3 | |
Scope | 4 |
Classifications | 6 |
Test methods | 7 |
Product inspection rules | 9 |
Marks labels and instructions | 10 |
Packaging transportation and storage | 12 |
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According to different according to GB/T after-expired sample amount of inspection amount of re-inspection Amount of sampling automatic operation method batches of kits Beijing CALCULATE the mean Carcinoembryonic antigen CEA Carcinoembryonic Antigen Quantitative CEA reagent chemiluminescent immunoassay reagent coefficient of variation correlation coefficient Device Registration Certificate documents so quoted enterprise shall provide Equation ex-factory inspection following contents inspection in batches inspection items Instructions for analytical instructions of reagent item is unqualified least the following linear correlation linear range M+2SD manual operation method manufacturing enterprise measurement procedure measurement results Medical Device Registration methods of 6.3 minimum detection limit ng/mL non-enzymatic chemiluminescent immunoassay Packaging PERFORM the detection period of validity procedure of traceability Product batch number Product name Product standard number quantitative determination reagent requirements of 5.8 results shall comply retained sample RLU values serum sample standard deviation SD terms and definitions traceability and corresponding Traceability The manufacturing type inspection variation CV zero-concentration calibrator