"Reagent kit for the quantitative determination of class M antibodies to cardiolipin by enzyme-linked immunosorbent assay" ("DS-ELISA-ANTI-CARDIOLIPIN-M") according to TU 21.20.23-250-05941003-2022 - Immunosorbent - 96-well collapsible polystyrene plate (up to the wells), in the wells of which cardiolipin with purified β2-glycoprotein 1 used as a co-factor is sorbed, ready for use: 1 plate; - Human IgM antibody conjugate, labeled with horseradish peroxidase, ready for use: 1 vial. 12.0 ml; - K+ - control positive sample, ready for use: 1 fl. 1.2 ml; - K- - control negative sample, ready for use: 1 fl. 2.5 ml; - Calibrators - calibrators containing known amounts of class M antibodies to cardiolipin are ready for use: Calibrator 0 - 1 fl. 1.0 ml, Calibrator 1 - 1 fl. 1.0 ml, Calibrator 2 ? 1 fl. 1.0 ml, Calibrator 3 ? 1 fl. 1.0 ml, Calibrator 4 - 1 vial. 1.0 ml, Calibrator 5 ? 1 fl. 1.0 ml; - BR - block solution for diluting serums, ready for use: 1 bottle. 12.5 ml; - PPC - solution for preliminary dilution of serums, ready for use: 1 bottle. 12.5 ml; - PR - flushing solution, concentrate (×25) of phosphate-saline buffer solution with twin (FSB-T): 1 fl. 50.0 ml; - Stop-reagent - sulfuric acid solution (0.2M), ready for use: 1 vial. 25.0 ml; - TMB-Substrate solution, ready to use: 1 fl. 14.0 ml; - tablet for pre-dilution of serums: 1 tablet; - protective film for ELISA tablets: 2 pcs.; - disposable tips: 16 pcs.; - plastic bath for liquid reagents: 2 pcs.; - plastic bag with Zip-Lock: 1 pc.; - Form for building a calibration graph: 1 pc.; - Instructions for use: 1 pc.
Russia·137290·LLC "NPO "Diagnostic Systems"·Registered January 27, 2023·Class 2a- Device Name (English)
- "Reagent kit for the quantitative determination of class M antibodies to cardiolipin by enzyme-linked immunosorbent assay" ("DS-ELISA-ANTI-CARDIOLIPIN-M") according to TU 21.20.23-250-05941003-2022 - Immunosorbent - 96-well collapsible polystyrene plate (up to the wells), in the wells of which cardiolipin with purified β2-glycoprotein 1 used as a co-factor is sorbed, ready for use: 1 plate; - Human IgM antibody conjugate, labeled with horseradish peroxidase, ready for use: 1 vial. 12.0 ml; - K+ - control positive sample, ready for use: 1 fl. 1.2 ml; - K- - control negative sample, ready for use: 1 fl. 2.5 ml; - Calibrators - calibrators containing known amounts of class M antibodies to cardiolipin are ready for use: Calibrator 0 - 1 fl. 1.0 ml, Calibrator 1 - 1 fl. 1.0 ml, Calibrator 2 ? 1 fl. 1.0 ml, Calibrator 3 ? 1 fl. 1.0 ml, Calibrator 4 - 1 vial. 1.0 ml, Calibrator 5 ? 1 fl. 1.0 ml; - BR - block solution for diluting serums, ready for use: 1 bottle. 12.5 ml; - PPC - solution for preliminary dilution of serums, ready for use: 1 bottle. 12.5 ml; - PR - flushing solution, concentrate (×25) of phosphate-saline buffer solution with twin (FSB-T): 1 fl. 50.0 ml; - Stop-reagent - sulfuric acid solution (0.2M), ready for use: 1 vial. 25.0 ml; - TMB-Substrate solution, ready to use: 1 fl. 14.0 ml; - tablet for pre-dilution of serums: 1 tablet; - protective film for ELISA tablets: 2 pcs.; - disposable tips: 16 pcs.; - plastic bath for liquid reagents: 2 pcs.; - plastic bag with Zip-Lock: 1 pc.; - Form for building a calibration graph: 1 pc.; - Instructions for use: 1 pc.
- Device Name (Russian)
- "Набор реагентов для количественного определения антител класса М к кардиолипину методом иммуноферментного анализа" ("ДС-ИФА-АНТИ-КАРДИОЛИПИН-М") по ТУ 21.20.23-250-05941003-2022 - Иммуносорбент - планшет полистироловый 96-луночный разборный (до лунок), в лунках которого сорбирован кардиолипин с очищенным β2-гликопротеином 1, используемым в качестве ко-фактора, готов к применению: 1 планшет; - Конъюгат - антитела к IgM человека, меченные пероксидазой хрена, готов к применению: 1 фл. 12,0 мл; - К+ - контрольный положительный образец, готов к применению: 1 фл. 1,2 мл; - К- - контрольный отрицательный образец, готов к применению: 1 фл. 2,5 мл; - Калибраторы - калибраторы, содержащие известные количества антител класса M к кардиолипину, готовы к применению: Калибратор 0 - 1 фл. 1,0 мл, Калибратор 1 - 1 фл. 1,0 мл, Калибратор 2 ? 1 фл. 1,0 мл, Калибратор 3 ? 1 фл. 1,0 мл, Калибратор 4 - 1 фл. 1,0 мл, Калибратор 5 ? 1 фл. 1,0 мл; - БР - блок-раствор для разведения сывороток, готов к применению: 1 фл. 12,5 мл; - РРС - раствор для предварительного разведения сывороток, готов к применению: 1 фл. 12,5 мл; - ПР - промывочный раствор, концентрат (×25) фосфатно-солевого буферного раствора с твином (ФСБ-Т): 1 фл. 50,0 мл; - Стоп-реагент - раствор серной кислоты (0,2М), готов к применению: 1 фл. 25,0 мл; - ТМБ-Субстратный раствор, готов к применению: 1 фл. 14,0 мл; - планшет для предварительного разведения сывороток: 1 планшет; - плёнка защитная для ИФА-планшетов: 2 шт.; - наконечники одноразовые: 16 шт.; - ванночка пластиковая для жидких реагентов: 2 шт.; - пакет полиэтиленовый с замком Zip-Lock: 1 шт.; - бланк для построения калибровочного графика: 1 шт.; - инструкция по применению: 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 137290
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 68003.0
- Registration Number
- РЗН 2023/19431
- Registration Date
- January 27, 2023
- Manufacturer Name (English)
- LLC "NPO "Diagnostic Systems"
- Manufacturer Name (Russian)
- ООО "НПО "Диагностические системы"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. NPO Diagnostic Systems LLC, 22 Yablunevaya St., Nizhny Novgorod, 603093, Russia. 2. NPO Diagnostic Systems LLC, 9B Barminskaya St., Nizhny Novgorod, 603022, Russia.
- Legal Address (Russian)
- 1. ООО "НПО "Диагностические системы", Россия, 603093, г. Нижний Новгород, ул. Яблоневая, д. 22. 2. ООО "НПО "Диагностические системы", Россия, 603022, г. Нижний Новгород, ул. Барминская, д. 9Б.
- Manufacturing Address
- 603157, Россия, г. Нижний Новгород, ул. Коминтерна, д. 47
Access comprehensive regulatory information for "Reagent kit for the quantitative determination of class M antibodies to cardiolipin by enzyme-linked immunosorbent assay" ("DS-ELISA-ANTI-CARDIOLIPIN-M") according to TU 21.20.23-250-05941003-2022 - Immunosorbent - 96-well collapsible polystyrene plate (up to the wells), in the wells of which cardiolipin with purified β2-glycoprotein 1 used as a co-factor is sorbed, ready for use: 1 plate; - Human IgM antibody conjugate, labeled with horseradish peroxidase, ready for use: 1 vial. 12.0 ml; - K+ - control positive sample, ready for use: 1 fl. 1.2 ml; - K- - control negative sample, ready for use: 1 fl. 2.5 ml; - Calibrators - calibrators containing known amounts of class M antibodies to cardiolipin are ready for use: Calibrator 0 - 1 fl. 1.0 ml, Calibrator 1 - 1 fl. 1.0 ml, Calibrator 2 ? 1 fl. 1.0 ml, Calibrator 3 ? 1 fl. 1.0 ml, Calibrator 4 - 1 vial. 1.0 ml, Calibrator 5 ? 1 fl. 1.0 ml; - BR - block solution for diluting serums, ready for use: 1 bottle. 12.5 ml; - PPC - solution for preliminary dilution of serums, ready for use: 1 bottle. 12.5 ml; - PR - flushing solution, concentrate (×25) of phosphate-saline buffer solution with twin (FSB-T): 1 fl. 50.0 ml; - Stop-reagent - sulfuric acid solution (0.2M), ready for use: 1 vial. 25.0 ml; - TMB-Substrate solution, ready to use: 1 fl. 14.0 ml; - tablet for pre-dilution of serums: 1 tablet; - protective film for ELISA tablets: 2 pcs.; - disposable tips: 16 pcs.; - plastic bath for liquid reagents: 2 pcs.; - plastic bag with Zip-Lock: 1 pc.; - Form for building a calibration graph: 1 pc.; - Instructions for use: 1 pc. 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 2023/19431 and manufactured by LLC "NPO "Diagnostic Systems". The device was registered on January 27, 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.