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Reagent kit for qualitative and quantitative determination of hepatitis D virus RNA in human blood plasma samples by real-time polymerase chain reaction with reverse transcription hybridization-fluorescence detection (RT-PCR-RV) "HEP-test-Q" according to TU 21.20.23-020-97638376-2020 , consisting of: 1. RT-PCR buffer - 1 tube, 480 μL. 2. Oligonucleotide mixture - 1 test tube, 1440 μl. 3. PCO - 1 tube, 50 μl. 4. OKO - 1 test tube, 1000 μl. 5. VKO - 1 test tube, 950 μl. 6. KO-1 - 2 test tubes, 1500 μl each. 7. KO-2 - 2 test tubes, 1500 μl each. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc. per batch. - Roszdravnadzor Registration РЗН 2022/18686

Access comprehensive regulatory information for Reagent kit for qualitative and quantitative determination of hepatitis D virus RNA in human blood plasma samples by real-time polymerase chain reaction with reverse transcription hybridization-fluorescence detection (RT-PCR-RV) "HEP-test-Q" according to TU 21.20.23-020-97638376-2020 , consisting of: 1. RT-PCR buffer - 1 tube, 480 μL. 2. Oligonucleotide mixture - 1 test tube, 1440 μl. 3. PCO - 1 tube, 50 μl. 4. OKO - 1 test tube, 1000 μl. 5. VKO - 1 test tube, 950 μl. 6. KO-1 - 2 test tubes, 1500 μl each. 7. KO-2 - 2 test tubes, 1500 μl each. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc. per batch. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2022/18686 and manufactured by LLC "TestGen". The device was registered on December 20, 2023.

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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РЗН 2022/18686
Reagent kit for qualitative and quantitative determination of hepatitis D virus RNA in human blood plasma samples by real-time polymerase chain reaction with reverse transcription hybridization-fluorescence detection (RT-PCR-RV) "HEP-test-Q" according to TU 21.20.23-020-97638376-2020 , consisting of: 1. RT-PCR buffer - 1 tube, 480 μL. 2. Oligonucleotide mixture - 1 test tube, 1440 μl. 3. PCO - 1 tube, 50 μl. 4. OKO - 1 test tube, 1000 μl. 5. VKO - 1 test tube, 950 μl. 6. KO-1 - 2 test tubes, 1500 μl each. 7. KO-2 - 2 test tubes, 1500 μl each. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc. per batch.
Набор реагентов для качественного и количественного определения РНК вируса гепатита D в образцах плазмы крови человека методом полимеразной цепной реакции в реальном времени с гибридизационно-флуоресцентной детекцией с обратной транскрипцией (ОТ-ПЦР-РВ) "НЕРА-D-тест-Q" по ТУ 21.20.23-020-97638376-2020 , в составе: 1. ОТ-ПЦР-буфер - 1 пробирка, 480 мкл. 2. Смесь олигонуклеотидов - 1 пробирка, 1440 мкл. 3. ПКО - 1 пробирка, 50 мкл. 4. ОКО - 1 пробирка, 1000 мкл. 5. ВКО - 1 пробирка, 950 мкл. 6. КО-1 - 2 пробирки, по 1500 мкл. 7. КО-2 - 2 пробирки, по 1500 мкл. 8. Инструкция по применению - 1 шт. 9. Паспорт качества - 1 шт. на партию.
Roszdravnadzor Registration Number: РЗН 2022/18686
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Device Information
Device Name (English)
Reagent kit for qualitative and quantitative determination of hepatitis D virus RNA in human blood plasma samples by real-time polymerase chain reaction with reverse transcription hybridization-fluorescence detection (RT-PCR-RV) "HEP-test-Q" according to TU 21.20.23-020-97638376-2020 , consisting of: 1. RT-PCR buffer - 1 tube, 480 μL. 2. Oligonucleotide mixture - 1 test tube, 1440 μl. 3. PCO - 1 tube, 50 μl. 4. OKO - 1 test tube, 1000 μl. 5. VKO - 1 test tube, 950 μl. 6. KO-1 - 2 test tubes, 1500 μl each. 7. KO-2 - 2 test tubes, 1500 μl each. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc. per batch.
Device Name (Russian)
Набор реагентов для качественного и количественного определения РНК вируса гепатита D в образцах плазмы крови человека методом полимеразной цепной реакции в реальном времени с гибридизационно-флуоресцентной детекцией с обратной транскрипцией (ОТ-ПЦР-РВ) "НЕРА-D-тест-Q" по ТУ 21.20.23-020-97638376-2020 , в составе: 1. ОТ-ПЦР-буфер - 1 пробирка, 480 мкл. 2. Смесь олигонуклеотидов - 1 пробирка, 1440 мкл. 3. ПКО - 1 пробирка, 50 мкл. 4. ОКО - 1 пробирка, 1000 мкл. 5. ВКО - 1 пробирка, 950 мкл. 6. КО-1 - 2 пробирки, по 1500 мкл. 7. КО-2 - 2 пробирки, по 1500 мкл. 8. Инструкция по применению - 1 шт. 9. Паспорт качества - 1 шт. на партию.
Device Type (English)
N/A
Device Type (Russian)
285280
Risk Class
N/A
OKPD Code
21.20.23.110
Registration Information
Registry Key
75754.0
Registration Number
РЗН 2022/18686
Registration Date
December 20, 2023
Manufacturer Information
Manufacturer Name (English)
LLC "TestGen"
Manufacturer Name (Russian)
ООО "ТестГен"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
1. TestGen LLC, Russia, 432072, Ulyanovsk, 44th Inzhenerny proezd, 9, pomeshch. 35, 36, 37. 2. NPP Biosfera LLC, 96 Vernadskogo Ave., Moscow, 119571, Russia. 3, 4, 5, 7, 8.
Legal Address (Russian)
1. ООО "ТестГен", Россия, 432072, г. Ульяновск, 44-й Инженерный пр-д, д. 9, помещ. 35, 36, 37. 2. ООО "НПП Биосфера", Россия, 119571, г. Москва, пр-кт Вернадского, д. 96, помещ. 3, 4, 5, 7, 8.
Manufacturing Address
432072, Россия, г. Ульяновск, 44-й Инженерный пр-д, д. 9, офис 13