Reagent kit for the detection and quantification of Human Herpesvirus 6 type A and B DNA (HHV6A / HHV6B) by polymerase chain reaction method with "real-time" detection "AmpliPrime® HHV6A / HHV6B" according to TU 21.20.23-199-09286667-2023 In versions: I. Dosage form 1, consisting of: 1. HHV6AB PCR mixture - 1.20 ml x 1 tube. 2. PCR buffer-H - 0.65 ml x 1 tube. 3. K1 HHV6AB - 0.12 mL x 1 tube. 4. K2 HHV6AB - 0.12 mL x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. II. Dosage form 2, consisting of: 1. HHV6AB PCR mixture - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. K1 HHV6AB - 0.12 mL x 1 tube. 4. K2 HHV6AB - 0.12 mL x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru.
Russia·224020·LLC "NextBio"·Registered April 01, 2024·Class 2b- Device Name (English)
- Reagent kit for the detection and quantification of Human Herpesvirus 6 type A and B DNA (HHV6A / HHV6B) by polymerase chain reaction method with "real-time" detection "AmpliPrime® HHV6A / HHV6B" according to TU 21.20.23-199-09286667-2023 In versions: I. Dosage form 1, consisting of: 1. HHV6AB PCR mixture - 1.20 ml x 1 tube. 2. PCR buffer-H - 0.65 ml x 1 tube. 3. K1 HHV6AB - 0.12 mL x 1 tube. 4. K2 HHV6AB - 0.12 mL x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. II. Dosage form 2, consisting of: 1. HHV6AB PCR mixture - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. K1 HHV6AB - 0.12 mL x 1 tube. 4. K2 HHV6AB - 0.12 mL x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru.
- Device Name (Russian)
- Набор реагентов для выявления и количественного определения ДНК Human Herpesvirus 6 типов А и В (HHV6A / HHV6B) методом полимеразной цепной реакции с детекцией в режиме "реального времени" "АмплиПрайм® HHV6A / HHV6B" по ТУ 21.20.23-199-09286667-2023 в вариантах исполнения: I. Форма выпуска 1, в составе: 1. ПЦР-смесь HHV6AB - 1,20 мл х 1 пробирка. 2. ПЦР-буфер-H - 0,65 мл х 1 пробирка. 3. K1 HHV6AB - 0,12 мл х 1 пробирка. 4. K2 HHV6AB - 0,12 мл х 1 пробирка. 5. ОКО - 1,10 мл х 1 пробирка. 6. К- - 0,26 мл х 1 пробирка. 7. Инструкция по применению набора в электронном виде на официальном сайте Производителя: www.nextbio.ru. 8. Краткое руководство по применению набора в бумажном виде. 9. Комплект вкладышей к набору в бумажном виде. 10. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru. II. Форма выпуска 2, в составе: 1. ПЦР-смесь HHV6AB - 0,01 мл х 100 пробирок (12,5 стрипов по 8 пробирок). 2. ПЦР-буфер-К - 1,20 мл х 1 пробирка. 3. K1 HHV6AB - 0,12 мл х 1 пробирка. 4. K2 HHV6AB - 0,12 мл х 1 пробирка. 5. ОКО - 1,10 мл х 1 пробирка. 6. К- - 0,26 мл х 1 пробирка. 7. Инструкция по применению набора в электронном виде на официальном сайте Производителя: www.nextbio.ru. 8. Краткое руководство по применению набора в бумажном виде. 9. Комплект вкладышей к набору в бумажном виде. 10. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru.
- Device Type (English)
- N/A
- Device Type (Russian)
- 224020
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 76641.0
- Registration Number
- РЗН 2024/22336
- Registration Date
- April 01, 2024
- Manufacturer Name (English)
- LLC "NextBio"
- Manufacturer Name (Russian)
- ООО "НекстБио"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- NextBio LLC, Russia, 111394, Moscow, Polimernaya str., 8, bldg. 2
- Legal Address (Russian)
- ООО "НекстБио", Россия, 111394, Москва, ул. Полимерная, д. 8, стр. 2
- Manufacturing Address
- 111394, Россия, Москва, ул. Полимерная, д. 8, стр. 2
Access comprehensive regulatory information for Reagent kit for the detection and quantification of Human Herpesvirus 6 type A and B DNA (HHV6A / HHV6B) by polymerase chain reaction method with "real-time" detection "AmpliPrime® HHV6A / HHV6B" according to TU 21.20.23-199-09286667-2023 In versions: I. Dosage form 1, consisting of: 1. HHV6AB PCR mixture - 1.20 ml x 1 tube. 2. PCR buffer-H - 0.65 ml x 1 tube. 3. K1 HHV6AB - 0.12 mL x 1 tube. 4. K2 HHV6AB - 0.12 mL x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. II. Dosage form 2, consisting of: 1. HHV6AB PCR mixture - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. PCR-buffer-K - 1.20 ml x 1 tube. 3. K1 HHV6AB - 0.12 mL x 1 tube. 4. K2 HHV6AB - 0.12 mL x 1 tube. 5. OKO - 1.10 ml x 1 tube. 6. K- - 0.26 ml x 1 test tube. 7. Instructions for the use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 8. A short guide to the use of the kit in paper form. 9. A set of inserts for the set in paper form. 10. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru. 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 2024/22336 and manufactured by LLC "NextBio". The device was registered on April 01, 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.