Reagent kit for qualitative and quantitative determination of HSV1, HSV2, CMV DNA in human biological material by PCR with "real-time" detection (Amplitech HSV1/HSV2/CMV (R)) according to TU 21.20.23-033-19926214-2023 Composed of: 1. Tablet with HSV1,2/CMV (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/.
Russia·327450·LLC "Amplitek"·Registered June 05, 2024·Class 2b- Device Name (English)
- Reagent kit for qualitative and quantitative determination of HSV1, HSV2, CMV DNA in human biological material by PCR with "real-time" detection (Amplitech HSV1/HSV2/CMV (R)) according to TU 21.20.23-033-19926214-2023 Composed of: 1. Tablet with HSV1,2/CMV (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 HSV1, HSV2, CMV в биологическом материале человека методом ПЦР с детекцией в режиме "реального времени" (Amplitech HSV1/HSV2/CMV (R)) по ТУ 21.20.23-033-19926214-2023 в составе: 1. Планшет со Смесью HSV1,2/CMV (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)
- 327450
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 76309.0
- Registration Number
- РЗН 2024/22806
- Registration Date
- June 05, 2024
- 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
Access comprehensive regulatory information for Reagent kit for qualitative and quantitative determination of HSV1, HSV2, CMV DNA in human biological material by PCR with "real-time" detection (Amplitech HSV1/HSV2/CMV (R)) according to TU 21.20.23-033-19926214-2023 Composed of: 1. Tablet with HSV1,2/CMV (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 2024/22806 and manufactured by LLC "Amplitek". The device was registered on June 05, 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.