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Reagent kit for pretreatment of biological material taken into the transport medium for liquid cytology "AmpliPrime® CITO-prep" according to TU 21.20.23-217-09286667-2023 Composed of: 1. M-lysine - 106.0 ml x 1 vial. 2. C-lysine - 11.0 ml x 1 vial. Set set: 1. Reagent kit - 1 pc. 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. A printed version of the instruction is available upon request by phone (495) 620-08-73. 3. A brief guide to the use of the kit in paper form - 1 pc. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru 5. Safety data sheets for M-lysine and C-lysine reagents at the request of the consumer in paper or electronic form. - Roszdravnadzor Registration РЗН 2024/22195

Access comprehensive regulatory information for Reagent kit for pretreatment of biological material taken into the transport medium for liquid cytology "AmpliPrime® CITO-prep" according to TU 21.20.23-217-09286667-2023 Composed of: 1. M-lysine - 106.0 ml x 1 vial. 2. C-lysine - 11.0 ml x 1 vial. Set set: 1. Reagent kit - 1 pc. 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. A printed version of the instruction is available upon request by phone (495) 620-08-73. 3. A brief guide to the use of the kit in paper form - 1 pc. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru 5. Safety data sheets for M-lysine and C-lysine reagents at the request of the consumer in paper or electronic form. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2024/22195 and manufactured by LLC "NextBio". The device was registered on March 11, 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 2a
РЗН 2024/22195
Reagent kit for pretreatment of biological material taken into the transport medium for liquid cytology "AmpliPrime® CITO-prep" according to TU 21.20.23-217-09286667-2023 Composed of: 1. M-lysine - 106.0 ml x 1 vial. 2. C-lysine - 11.0 ml x 1 vial. Set set: 1. Reagent kit - 1 pc. 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. A printed version of the instruction is available upon request by phone (495) 620-08-73. 3. A brief guide to the use of the kit in paper form - 1 pc. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru 5. Safety data sheets for M-lysine and C-lysine reagents at the request of the consumer in paper or electronic form.
Набор реагентов для предобработки биологического материала, взятого в транспортную среду для жидкостной цитологии "АмплиПрайм® ЦИТО-преп" по ТУ 21.20.23-217-09286667-2023 в составе: 1. М-лизин - 106,0 мл х 1 флакон. 2. С-лизин - 11,0 мл х 1 флакон. Комплектность набора: 1. Набор реагентов - 1 шт. 2. Инструкция по применению набора в электронном виде на официальном сайте Производителя: www.nextbio.ru. Печатная версия инструкции доступна по запросу по телефону (495) 620-08-73. 3. Краткое руководство по применению набора в бумажном виде - 1 шт. 4. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru 5. Листы безопасности реагентов М-лизин и С-лизин по запросу потребителя в бумажном или электронном виде.
Roszdravnadzor Registration Number: РЗН 2024/22195
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Device Information
Device Name (English)
Reagent kit for pretreatment of biological material taken into the transport medium for liquid cytology "AmpliPrime® CITO-prep" according to TU 21.20.23-217-09286667-2023 Composed of: 1. M-lysine - 106.0 ml x 1 vial. 2. C-lysine - 11.0 ml x 1 vial. Set set: 1. Reagent kit - 1 pc. 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. A printed version of the instruction is available upon request by phone (495) 620-08-73. 3. A brief guide to the use of the kit in paper form - 1 pc. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru 5. Safety data sheets for M-lysine and C-lysine reagents at the request of the consumer in paper or electronic form.
Device Name (Russian)
Набор реагентов для предобработки биологического материала, взятого в транспортную среду для жидкостной цитологии "АмплиПрайм® ЦИТО-преп" по ТУ 21.20.23-217-09286667-2023 в составе: 1. М-лизин - 106,0 мл х 1 флакон. 2. С-лизин - 11,0 мл х 1 флакон. Комплектность набора: 1. Набор реагентов - 1 шт. 2. Инструкция по применению набора в электронном виде на официальном сайте Производителя: www.nextbio.ru. Печатная версия инструкции доступна по запросу по телефону (495) 620-08-73. 3. Краткое руководство по применению набора в бумажном виде - 1 шт. 4. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru 5. Листы безопасности реагентов М-лизин и С-лизин по запросу потребителя в бумажном или электронном виде.
Device Type (English)
N/A
Device Type (Russian)
186170
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
75439.0
Registration Number
РЗН 2024/22195
Registration Date
March 11, 2024
Manufacturer Information
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, г. Москва, ул. Полимерная, д. 8, стр. 2
Manufacturing Address
111394, Россия, Москва, ул. Полимерная, д. 8, стр. 2