Reported Lead-Acid Battery Fees Due by Return Filing PeriodNote * Page 1 of 4 Fiscal Year Manufacturer Battery Fee California Battery Fee Total FY 16-17 $ 2,511,494 $ 1,597,699 $ 4,109,193 FY 17-18 $ 10,207,023 $ 7,120,807 $ 17,327,830 FY 18-19 $ 9,251,918 $ 6,171,244 $ 15,423,162 FY 19-20 $ 10,312,433 $ 6,625,463 $ 16,937,896 FY 20-21 $ 9,953,704 22,899,291 FY 22-23 $ 19,777,690 $ 13,687,089 $ 33,098,401Note ** Page 1 of 4 Fy 23-24 $ 17,097,260 $ 14,229,009
Sequencing Method: in-house Genotypic antiretroviral resistance testingof HIV using Sanger sequencing (V7270) Nucleic acid extraction: BioMérieux EasyMag automated platform, with NucliSENS extraction reagents (as per manufacturer's instructions) Amplification: Bio-RAD Dyad DNA engine thermal cycler Gel electrophoresis and PCR cleanup using ThermoFisher exoSap-it(V7255)扩增子的定量:热泡量QUBIT 2.0荧光计(V7064)为抗病毒抗性测试(V7256)核酸序列数据制备Sanger测序反应
SECTION 2.SCOPE 第 2 部分 范围 This guidance describes how certain provisions of the medical device Quality System regulation apply to software and the agency’s current approach to evaluating a software validation system.For example, this document lists elements that are acceptable to the FDA for the validation of software; however, it does not list all of the activities and tasks that must, in all instances, be used to comply with the law.本指导描述了医疗器械质量系统法规的某些条款如何应用到软件,以及 FDA 评价一个软件验证系统的 现行方法。例如,本文列出了 FDA 对于软件验证的可接受元素;但是,并未列出在一切情况下必须遵 循法律的所有活动和任务。 The scope of this guidance is somewhat broader than the scope of validation in the strictest definition of that term.Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering discussed in this guidance are important activities that together help to support a final conclusion that software is validated.严格上讲,本指导的应用范围比验证的范围更广泛一些。计划、确认、测试、追溯性、配置管理及本 指导中讨论的良好软件工程的许多其他方面是重要的活动,它们有助于支持一个最终结论 - 软件是已验 证过的。 This guidance recommends an integration of software life cycle management and risk management activities.Based on the intended use and the safety risk associated with the software to be developed, the software developer should determine the specific approach, the combination of techniques to be used, and the level of effort to be applied.While this guidance does not recommend any specific life cycle model or any specific technique or method, it does recommend that software validation and verification activities be conducted throughout the entire software life cycle.本指导建议将软件生命周期管理和风险管理活动进行整合。根据预期用途和与开发的软件相关联的安 全风险,软件开发人员应确定特定方法,使用的多个技术的组合,以及应用尝试程度。虽然本指导未 推荐任何特定生命周期模式,或任何特定技术或方法,但建议整个软件生命周期需进行软件验证和确 认活动。 Where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software) the software developer may not be directly responsible for compliance with FDA regulations.若软件由某人而非器械生产商开发,如成品组件软件,这个软件开发者可能不直接负责 FDA 法规的符 合性。 In that case, the party with regulatory responsibility (i.e., the device manufacturer) needs to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts are needed to establish that the software is validated for the device manufacturer’s intended use.
Characteristics Alkaline Electrolyzer PEM Electrolyzer Model Name OK-300/500 QL-300 Manufacturer Hunan Moreshine [8] Shandong Saikesaisi Hydrogen Energy Co. Ltd [9] Tag Price BDT 53500 BDT 108066 Hydrogen purity 99.999% 99.99% Production rate 272 mL/min or 0.0162 Nm 3 /h (STP) 272毫升/分钟或0.0162 nm 3/h(STP)用电120W 150W尺寸420x210x365(mm)420 x 227 x 352(mm)重量13kg 13kg 13kg 15kg 15kg环境条件环境和无尘的环境和无尘的环境和无尘的环境和无尘
体现的碳:在建筑物或基础设施的整个生命周期中,与材料和建设过程相关的温室气体排放。Embodied carbon includes: material extraction and upstream production (A1), transport to manufacturer/factory (A2), manufacturing (A3), transport to site (A4), construction and installation processes (A5), use phase (B1), maintenance (B2), repair (B3), replacement of building components (B4), renovation (B5), deconstruction (C1), transport to end-of-life设施(C2),重复使用,恢复或回收(C3)和废物处理(C4)的处理(C4)。产品再利用,材料回收和导出的能源 /能量回收率(d)以外的益处和负载应根据EN 15978及相关标准分别报告。
・ You don't know how to use opto-semiconductors ・ You don't know what type of detection circuit is optimal ・ Your circuit is not stable ・ You want to reduce mounting space ・ You want to reduce the number of components ・ Your circuit oscillates ・ You want to know how to select components ・ You want to add a function ・ Another manufacturer's product has been discontinued ・ Noise suppression is a problem ・ You want to reduce power消费・有很多参数,您无法掌握它们・ comparulas很难
(b)计算应用ZEV百分比的车辆数量。为了计算制造商在2009年至2017年的模型年度中的制造商的需求。制造商可以每年切换方法。此产品平均用于确定C.2.1(a)中指定的ZEV要求,并且对制造商的尺寸确定没有影响,该确定规定于第1900节。例如,在应用ZEV需求时,由一家制造商(例如制造商A)生产的PC,LDT1或LDT2,但由另一家制造商(例如,制造商B)在加利福尼亚州销售,由其他制造商(制造商B)(制造商B)在制造商中均由Marketing Brograstrans Marketsranter(制造商)销售。
剂量:_____ /______ /____制造商________剂量: / / /____制造商________ M. D Y M. D Y M. D Y M. D Y M. D Y M. D Y M. D Y M. D Y M. D Y M. D Y M. ____ /____制造商____________剂量: / / /____制造商____________ M. D y M. D y M. D Y M. D Y M. D Y M. DOSE: /_____________________ /DIV Y Y < /div y < /div y < /div y < /div y < /div>
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授权疫苗和被动免疫剂(例如免疫球蛋白和抗毒素,具有现成的抗体)的授权疫苗和被动免疫剂(例如,现成的抗体)的商业名称免疫剂子集(代表疫苗品牌名称)。此子集是加拿大卫生Infoway开发的加拿大Snomed CT参考集的直接扩展。Where available, each SNOMED CT tradename is also linked to its corresponding Health Canada issued unique Drug Identification Number (DIN), lot numbers (assigned by the manufacturer to each vaccine batch), SNOMED CT generic immunization agent concept (representing the non-brand name), vaccine preventable disease concept (indicating the disease the vaccine protects against), and antigen concept (representing the active ingredient triggering an immune 回复)。