Reagent kit for calibration "MagnoLIA intact PTH calibrators", according to TU 21.20.23-668-98539446-2023 Options: I. Version 1: 1. Set "MagnoLIA intact PTH calibrators", consisting of: - Calibration sample No1, marked "Calibrator 1" - 1 pc.; - Calibration sample No2, marked "Calibrator 2" - 1 pc.; - Calibration sample No3, marked "Calibrator 3" - 1 pc.; - Calibration sample No4, marked "Calibrator 4" - 1 pc.; The delivery set includes: a set of reagents, instructions for use, passport. II. Version 2: 1. Set "MagnoLIA intact PTH calibrators", consisting of: - Calibration sample No1, marked "Calibrator 1" - 5 pcs.; - Calibration sample No2, marked "Calibrator 2" - 5 pcs.; - Calibration sample No3, marked "Calibrator 3" - 5 pcs.; - Calibration sample No4, marked "Calibrator 4" - 5 pcs.; The delivery set includes: a set of reagents, instructions for use, passport.
- Device Name (English)
- Reagent kit for calibration "MagnoLIA intact PTH calibrators", according to TU 21.20.23-668-98539446-2023 Options: I. Version 1: 1. Set "MagnoLIA intact PTH calibrators", consisting of: - Calibration sample No1, marked "Calibrator 1" - 1 pc.; - Calibration sample No2, marked "Calibrator 2" - 1 pc.; - Calibration sample No3, marked "Calibrator 3" - 1 pc.; - Calibration sample No4, marked "Calibrator 4" - 1 pc.; The delivery set includes: a set of reagents, instructions for use, passport. II. Version 2: 1. Set "MagnoLIA intact PTH calibrators", consisting of: - Calibration sample No1, marked "Calibrator 1" - 5 pcs.; - Calibration sample No2, marked "Calibrator 2" - 5 pcs.; - Calibration sample No3, marked "Calibrator 3" - 5 pcs.; - Calibration sample No4, marked "Calibrator 4" - 5 pcs.; The delivery set includes: a set of reagents, instructions for use, passport.
- Device Name (Russian)
- Набор реагентов для калибровки "Калибраторы MagnoLIA интактный ПТГ", по ТУ 21.20.23-668-98539446-2023 , варианты исполнения: I. Вариант исполнения 1: 1. Набор «Калибраторы MagnoLIA интактный ПТГ», в составе: - Калибровочная проба №1, маркирована «Калибратор 1» - 1 шт.; - Калибровочная проба №2, маркирована «Калибратор 2» - 1 шт.; - Калибровочная проба №3, маркирована «Калибратор 3» - 1 шт.; - Калибровочная проба №4, маркирована «Калибратор 4» - 1 шт.; В комплект поставки входят: набор реагентов, инструкция по применению, паспорт. II. Вариант исполнения 2: 1. Набор «Калибраторы MagnoLIA интактный ПТГ», в составе: - Калибровочная проба №1, маркирована «Калибратор 1» - 5 шт.; - Калибровочная проба №2, маркирована «Калибратор 2» - 5 шт.; - Калибровочная проба №3, маркирована «Калибратор 3» - 5 шт.; - Калибровочная проба №4, маркирована «Калибратор 4» - 5 шт.; В комплект поставки входят: набор реагентов, инструкция по применению, паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 142480
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78040.0
- Registration Number
- РЗН 2024/22891
- Registration Date
- June 10, 2024
- Manufacturer Name (English)
- Alkor Bio Company LLC
- Manufacturer Name (Russian)
- ООО "Компания Алкор Био"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- Alkor Bio Company, LLC, St. Petersburg, 192148, Russia, Zheleznodorozhny prospekt, 40, letter A
- Legal Address (Russian)
- ООО "Компания Алкор Био", Россия, 192148, Санкт-Петербург, Железнодорожный пр-кт, д. 40, литера А
- Manufacturing Address
- 192148, Россия, Санкт-Петербург, Железнодорожный пр-кт, д. 40, литера А, офис 217
Access comprehensive regulatory information for Reagent kit for calibration "MagnoLIA intact PTH calibrators", according to TU 21.20.23-668-98539446-2023 Options: I. Version 1: 1. Set "MagnoLIA intact PTH calibrators", consisting of: - Calibration sample No1, marked "Calibrator 1" - 1 pc.; - Calibration sample No2, marked "Calibrator 2" - 1 pc.; - Calibration sample No3, marked "Calibrator 3" - 1 pc.; - Calibration sample No4, marked "Calibrator 4" - 1 pc.; The delivery set includes: a set of reagents, instructions for use, passport. II. Version 2: 1. Set "MagnoLIA intact PTH calibrators", consisting of: - Calibration sample No1, marked "Calibrator 1" - 5 pcs.; - Calibration sample No2, marked "Calibrator 2" - 5 pcs.; - Calibration sample No3, marked "Calibrator 3" - 5 pcs.; - Calibration sample No4, marked "Calibrator 4" - 5 pcs.; The delivery set includes: a set of reagents, instructions for use, passport. 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 2024/22891 and manufactured by Alkor Bio Company LLC. The device was registered on June 10, 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.