Reagent kit for enzyme-linked immunosorbent detection of IgM antibodies to Toxoplasma gondii antigens in blood serum (plasma) "Toxoplasma IgM-ELISA" according to TU 21.20.23-701-18619450-2023 Composed of: - tablet - 1 pc.; - negative control - 1 x 0.5 ml; - positive control - 1 x 0.2 ml; - conjugate - 1 x 14 ml; - ELISA-Buffer - 1 x 14 ml; - Tetramethylbenzidine substrate solution (TMB) - 1 x 14 ml; - washing solution concentrate - 1 x 22 ml; - stop reagent - 1 x 14 ml; - paper for gluing a tablet - 2 pcs.; - instructions for use - 1 pc.; - Quality control passport (analytical passport) - 1 pc.
Russia·255190·HEMA LLC·Registered March 04, 2024·Class 2b- Device Name (English)
- Reagent kit for enzyme-linked immunosorbent detection of IgM antibodies to Toxoplasma gondii antigens in blood serum (plasma) "Toxoplasma IgM-ELISA" according to TU 21.20.23-701-18619450-2023 Composed of: - tablet - 1 pc.; - negative control - 1 x 0.5 ml; - positive control - 1 x 0.2 ml; - conjugate - 1 x 14 ml; - ELISA-Buffer - 1 x 14 ml; - Tetramethylbenzidine substrate solution (TMB) - 1 x 14 ml; - washing solution concentrate - 1 x 22 ml; - stop reagent - 1 x 14 ml; - paper for gluing a tablet - 2 pcs.; - instructions for use - 1 pc.; - Quality control passport (analytical passport) - 1 pc.
- Device Name (Russian)
- Набор реагентов для иммуноферментного выявления IgM антител к антигенам Toxoplasma gondii в сыворотке (плазме) крови "Toxoplasma IgM-ИФА" по ТУ 21.20.23-701-18619450-2023 в составе: - планшет - 1 шт.; - отрицательный контроль - 1 х 0,5 мл; - положительный контроль - 1 х 0,2 мл; - конъюгат - 1 х 14 мл; - ИФА-Буфер - 1 х 14 мл; - субстратный раствор тетраметилбензидина (ТМБ) - 1 x 14 мл; - концентрат отмывочного раствора - 1 х 22 мл; - стоп-реагент - 1 x 14 мл; - бумага для заклеивания планшет - 2 шт.; - инструкция по применению - 1 шт.; - паспорт контроля качества (аналитический паспорт) - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 255190
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 76213.0
- Registration Number
- РЗН 2024/22123
- Registration Date
- March 04, 2024
- Manufacturer Name (English)
- HEMA LLC
- Manufacturer Name (Russian)
- ООО "ХЕМА"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- LLC "KEMA", Russia, 143900, Moscow region, Balashikha, Trubetskaya str., vld. 2B
- Legal Address (Russian)
- ООО "ХЕМА", Россия, 143900, Московская область, г. Балашиха, ул. Трубецкая, влд. 2В
- Manufacturing Address
- 125319, Россия, Москва, ул. 4-я 8 марта, д. 3, к. 3, помещ. 2
Access comprehensive regulatory information for Reagent kit for enzyme-linked immunosorbent detection of IgM antibodies to Toxoplasma gondii antigens in blood serum (plasma) "Toxoplasma IgM-ELISA" according to TU 21.20.23-701-18619450-2023 Composed of: - tablet - 1 pc.; - negative control - 1 x 0.5 ml; - positive control - 1 x 0.2 ml; - conjugate - 1 x 14 ml; - ELISA-Buffer - 1 x 14 ml; - Tetramethylbenzidine substrate solution (TMB) - 1 x 14 ml; - washing solution concentrate - 1 x 22 ml; - stop reagent - 1 x 14 ml; - paper for gluing a tablet - 2 pcs.; - instructions for use - 1 pc.; - Quality control passport (analytical passport) - 1 pc. 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 2024/22123 and manufactured by HEMA LLC. The device was registered on March 04, 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.