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俄罗斯RZN加快部分急需器械注册审批(清单)
日期:2022年07月31日

俄罗斯为防止市场上出现某些医疗器械的供应短缺,特地简化了部分医疗器械的注册流程,以下是我为大家整理的这部分产品的清单:

编码

描述

107660

全自动IVD质谱分析仪

107670

半自动IVD质谱分析仪

209280

IVD样本制备装置

261700

实验室瓶

318650

用于分离IVD周围磁颗粒的装置

325350

IVD免疫荧光/分光光度分析仪

339870

IVD核酸测序仪

190110

琥珀酰丙酮IVD试剂

194750

多种氨基酸/肉碱代谢物IVD试剂3

198560

多重类固醇激素IVD,试剂盒,质谱分析

339500

多种氨基酸/肉碱代谢物IVD,试剂盒,MS/LC

192300

多种氨基酸/肉碱代谢物IVD,试剂盒,质谱分析

128100

新生儿甲状腺素(新生儿T4) IVD试剂盒,免疫荧光测定

128270

新生儿甲状腺素(新生儿T4) IVD试剂盒,酶免疫分析(ELISA)

103010

游离皮质醇IVD试剂盒酶联免疫吸附试验(ELISA)

205040

总皮质醇IVD控制物质

205060

总皮质醇IVD,试剂

231180

促肾上腺皮质激素(ACTH) IVD,试剂盒,免疫组化酶标

231220

促肾上腺皮质激素(ACTH) IVD,抗体

231230

促肾上腺皮质激素(ACTH) IVD试剂盒(RIA)

231250

促肾上腺皮质激素(ACTH) IVD,校准器

231260

促肾上腺皮质激素(ACTH) IVD,试剂盒,免疫化学发光法

231290

促肾上腺皮质激素(ACTH) IVD对照

304500

17-羟基孕酮IVD,试剂

275570

醛固酮IVD对照材料

275580

醛固酮IVD试剂盒,放射免疫分析法(RIA)

275610

醛固酮试管,试剂

336570

醛固酮IVD,试剂盒,免疫化学发光检测

304460

17-羟基孕酮IVD试剂盒酶分光光度法测定

304510

17-羟基孕酮IVD试剂盒(RIA)

192830

多重正痘病毒核酸IVD,校准器

196790

多重正痘病毒核酸IVD对照材料

196800

多种正痘病毒核酸IVD试剂盒,核酸分析

196810

多重正痘病毒核酸IVD,试剂

334260

多种正痘病毒抗原IVD试剂盒(ELISA)

349780

多种正痘病毒抗体IVD,试剂

- *

多种正痘病毒抗原IVD,试剂盒,预免疫分析法,快速分析



The list of Medical Devices for the simplified registration process in accordance to prevent deficiency of such MDs on the Russian market


Type (code)

Description

 

107660

Mass spectrometric analyzer IVD, automatic
 
 

107670

Mass spectrometric analyzer IVD, semi-automatic
 
 

209280

IVD sample preparation device, external
 
 

261700

Lab shaker3

318650

Device for separating the magnetic particles of  the IVD surrounding

325350

IVD Immunofluorescence/Spectrophotometric  Analyzer, for use near  the patient

339870

IVD Nucleic Acid Sequencer, Sanger Sequencing

190110

Succinylacetone IVD, reagent

194750

Multiple Amino Acids/Carnitine Metabolites IVD  Reagent

198560

Multiple steroid hormones IVD, kit, mass  spectrometric analysis
 
 

339500

Multiple amino acids/carnitine metabolites IVD,  kit, MS/LC
 
 

192300

Multiple amino acids/carnitine metabolites IVD,  kit, mass spectrometric analysis

128100

Neonatal thyroxin (neonatal T4) IVD, kit,  immunofluorescence assay

128270

Neonatal thyroxine (neonatal T4) IVD, kit,  enzyme immunoassay (ELISA)

103010

Free cortisol IVD, kit, enzyme-linked  immunosorbent assay (ELISA)

205040

Total cortisol IVD control material

231180

Adrenocorticotropic hormone (ACTH) IVD, kit,  immunohistochemical enzyme label

231220

Adrenocorticotropic hormone (ACTH) IVD,  antibodies

231230

Adrenocorticotropic hormone (ACTH) IVD kit,  radioimmunoassay (RIA)
 
 

231250

Adrenocorticotropic hormone (ACTH) IVD,  calibrator

231260

Adrenocorticotropic hormone (ACTH) IVD, kit,  immunochemiluminescent assay

231290

Adrenocorticotropic hormone (ACTH) IVD control  material

304500

17-hydroxycorticoid IVD, reagent
 
 

275570

Aldosterone IVD control material

275580
 
 

Aldosterone IVD, kit, radioimmunoassay (RIA)

275610

Aldosterone IVD, reagent

336570

Aldosterone IVD, kit, immunochemiluminescent  assay

304460 -

17-Hydroxyprogesterone IVD Kit Enzyme  Spectrophotometric Assay

304510

17-hydroxyprogesterone IVD kit, radioimmunoassay  (RIA)

192830
 
 

Multiple orthopoxvirus nucleic acids IVD,  calibrator

196790
 
 

Multiple orthopoxvirus nucleic acid IVD control  material

196800

Multiple orthopoxviruses nucleic acid IVD kit,  nucleic acid analysis
 
 

196810

Multiple orthopoxvirus nucleic acid IVD, reagent
 
 

334260
 
 

Multiple orthopoxvirus antigens IVD kit, enzyme  immunoassay (ELISA)

349780

Multiple orthopoxvirus antibodies IVD, reagent
 
 

- *

Multiple orthopoxvirus antigens IVD, kit,  pre-immunoassay method, rapid analysis

 


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