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Reagent kit for qualitative and quantitative determination of DNA of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis in human biological material by PCR with real-time detection (Amplitech CNMT (R)) according to TU 21.20.23-028-19926214-2023 Composed of: 1. Tablet with CNMT (R) Mixture - 1 pc. 2. Films for the tablet - 2 pcs. 3. OK - 0.8 ml x 1 tube. 4. PC U - 0.8 ml x 1 tube. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc in paper form. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. - Roszdravnadzor Registration РЗН 2024/22802

Access comprehensive regulatory information for Reagent kit for qualitative and quantitative determination of DNA of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis in human biological material by PCR with real-time detection (Amplitech CNMT (R)) according to TU 21.20.23-028-19926214-2023 Composed of: 1. Tablet with CNMT (R) Mixture - 1 pc. 2. Films for the tablet - 2 pcs. 3. OK - 0.8 ml x 1 tube. 4. PC U - 0.8 ml x 1 tube. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc in paper form. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2024/22802 and manufactured by LLC "Amplitek". The device was registered on May 30, 2024.

This page provides complete registration details including device type, manufacturer information, country of origin (Russia), and regulatory compliance data from the official Russia Roszdravnadzor medical device database. Pure Global AI offers free access to Russia's complete medical device registry, helping global MedTech companies navigate Roszdravnadzor regulations efficiently.

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Class 2b
РЗН 2024/22802
Reagent kit for qualitative and quantitative determination of DNA of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis in human biological material by PCR with real-time detection (Amplitech CNMT (R)) according to TU 21.20.23-028-19926214-2023 Composed of: 1. Tablet with CNMT (R) Mixture - 1 pc. 2. Films for the tablet - 2 pcs. 3. OK - 0.8 ml x 1 tube. 4. PC U - 0.8 ml x 1 tube. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc in paper form. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/.
Набор реагентов для качественного и количественного определения ДНК Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium и Trichomonas vaginalis в биологическом материале человека методом ПЦР с детекцией в режиме "реального времени" (Amplitech CNMT (R)) по ТУ 21.20.23-028-19926214-2023 в составе: 1. Планшет со Смесью CNMT (R) - 1 шт. 2. Плёнки для планшета - 2 шт. 3. ОК - 0,8 мл х 1 пробирка. 4. ПК U - 0,8 мл х 1 пробирка. 5. Инструкция по применению - 1 шт. В бумажном виде и электронном виде по адресу: http://www.amplitech.ru/resources/. 6. Краткое руководство - 1 шт. В бумажном виде. 7. Паспорт - 1 шт. В электронном виде по адресу: http://www.amplitech.ru/quality/.
Roszdravnadzor Registration Number: РЗН 2024/22802
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Device Information
Device Name (English)
Reagent kit for qualitative and quantitative determination of DNA of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis in human biological material by PCR with real-time detection (Amplitech CNMT (R)) according to TU 21.20.23-028-19926214-2023 Composed of: 1. Tablet with CNMT (R) Mixture - 1 pc. 2. Films for the tablet - 2 pcs. 3. OK - 0.8 ml x 1 tube. 4. PC U - 0.8 ml x 1 tube. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc in paper form. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/.
Device Name (Russian)
Набор реагентов для качественного и количественного определения ДНК Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium и Trichomonas vaginalis в биологическом материале человека методом ПЦР с детекцией в режиме "реального времени" (Amplitech CNMT (R)) по ТУ 21.20.23-028-19926214-2023 в составе: 1. Планшет со Смесью CNMT (R) - 1 шт. 2. Плёнки для планшета - 2 шт. 3. ОК - 0,8 мл х 1 пробирка. 4. ПК U - 0,8 мл х 1 пробирка. 5. Инструкция по применению - 1 шт. В бумажном виде и электронном виде по адресу: http://www.amplitech.ru/resources/. 6. Краткое руководство - 1 шт. В бумажном виде. 7. Паспорт - 1 шт. В электронном виде по адресу: http://www.amplitech.ru/quality/.
Device Type (English)
N/A
Device Type (Russian)
199980
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
76264.0
Registration Number
РЗН 2024/22802
Registration Date
May 30, 2024
Manufacturer Information
Manufacturer Name (English)
LLC "Amplitek"
Manufacturer Name (Russian)
ООО "Амплитек"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
LLC "Amplitek", Russia, 109235, Moscow, 1st Kuryanovskaya str., 34, bldg. 8, fl. 1, room. II
Legal Address (Russian)
ООО "Амплитек", Россия, 109235, г. Москва, ул. 1-я Курьяновская, д. 34, стр. 8, эт. 1, помещ. II
Manufacturing Address
109235, Россия, Москва, ул. 1-я Курьяновская, д. 34, стр. 8, эт. 1, помещ. II, ком. 42