Reagent kit for quantitative immunochemiluminescence determination of intact parathyroid hormone "MagnoLIA intact PTH", according to TU 21.20.23-667-98539446-2023 Options: I. Version 1: 1. Cartridge marked "MagnoLIA intact PTH" - 1 pc., containing: - paramagnetic microparticles with immobilized antibodies to intact PTH (MC). Suspension, 10 mL, cartridge compartment; - anti-PTH conjugate with acridine label (A*). Fatness, 5 ml, cartridge compartment. The delivery set includes: a set of reagents, instructions for use, passport. II. Version 2: 1. Cartridge marked "MagnoLIA intact PTH" - 2 pcs., containing: - paramagnetic microparticles with immobilized antibodies to intact PTH (MC). Suspension, 10 mL, cartridge compartment; - anti-PTH conjugate with acridine label (A*). Fatness, 5 ml, cartridge compartment. The delivery set includes: a set of reagents, instructions for use, passport.
Russia·142490·Alkor Bio Company LLC·Registered June 10, 2024·Class 2a- Device Name (English)
- Reagent kit for quantitative immunochemiluminescence determination of intact parathyroid hormone "MagnoLIA intact PTH", according to TU 21.20.23-667-98539446-2023 Options: I. Version 1: 1. Cartridge marked "MagnoLIA intact PTH" - 1 pc., containing: - paramagnetic microparticles with immobilized antibodies to intact PTH (MC). Suspension, 10 mL, cartridge compartment; - anti-PTH conjugate with acridine label (A*). Fatness, 5 ml, cartridge compartment. The delivery set includes: a set of reagents, instructions for use, passport. II. Version 2: 1. Cartridge marked "MagnoLIA intact PTH" - 2 pcs., containing: - paramagnetic microparticles with immobilized antibodies to intact PTH (MC). Suspension, 10 mL, cartridge compartment; - anti-PTH conjugate with acridine label (A*). Fatness, 5 ml, cartridge compartment. The delivery set includes: a set of reagents, instructions for use, passport.
- Device Name (Russian)
- Набор реагентов для количественного иммунохемилюминесцентного определения интактного паратиреоидного гормона "MagnoLIA интактный ПТГ", по ТУ 21.20.23-667-98539446-2023 , варианты исполнения: I. Вариант исполнения 1: 1. Картридж, маркированный «MagnoLIA интактный ПТГ» - 1 шт., в составе: - парамагнитные микрочастицы с иммобилизованными антителами к интактному ПТГ (МЧ). Суспензия, 10 мл, отсек картриджа; - конъюгат анти-ПТГ с акридиновой меткой (А*). Ж идкость, 5 мл, отсек картриджа. В комплект поставки входят: набор реагентов, инструкция по применению, паспорт. II. Вариант исполнения 2: 1. Картридж, маркированный «MagnoLIA интактный ПТГ» - 2 шт., в составе: - парамагнитные микрочастицы с иммобилизованными антителами к интактному ПТГ (МЧ). Суспензия, 10 мл, отсек картриджа; - конъюгат анти-ПТГ с акридиновой меткой (А*). Ж идкость, 5 мл, отсек картриджа. В комплект поставки входят: набор реагентов, инструкция по применению, паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 142490
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78042.0
- Registration Number
- РЗН 2024/22889
- 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 quantitative immunochemiluminescence determination of intact parathyroid hormone "MagnoLIA intact PTH", according to TU 21.20.23-667-98539446-2023 Options: I. Version 1: 1. Cartridge marked "MagnoLIA intact PTH" - 1 pc., containing: - paramagnetic microparticles with immobilized antibodies to intact PTH (MC). Suspension, 10 mL, cartridge compartment; - anti-PTH conjugate with acridine label (A*). Fatness, 5 ml, cartridge compartment. The delivery set includes: a set of reagents, instructions for use, passport. II. Version 2: 1. Cartridge marked "MagnoLIA intact PTH" - 2 pcs., containing: - paramagnetic microparticles with immobilized antibodies to intact PTH (MC). Suspension, 10 mL, cartridge compartment; - anti-PTH conjugate with acridine label (A*). Fatness, 5 ml, cartridge compartment. 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 2024/22889 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.