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Reagent kit for enzyme-linked immunosorbent assay of IgG antigens to Cytomegalovirus antigens in blood serum (plasma) "Cytomegalovirus IgG-ELISA" Composed of: 1. Tablet - 1 pc. 2. Calibration samples - 5 x 1.5 ml. 3. Control serum - 1 x 1.5 ml. 4. Conjugate - 1 x 14 ml. 5. ELISA Buffer - 1 x 50 ml. 6. Tetramethylbenzidine (TMB) substrate solution - 1 x 14 ml. 7. Washing solution concentrate - 1 x 22 ml. 8. Stop reagent - 1 x 14 ml. 9. Paper for gluing tablet - 2 pcs. 10. Instructions for use - 1 pc. 11. Quality control passport (analytical passport) - 1 pc. - Roszdravnadzor Registration РЗН 2023/21476

Access comprehensive regulatory information for Reagent kit for enzyme-linked immunosorbent assay of IgG antigens to Cytomegalovirus antigens in blood serum (plasma) "Cytomegalovirus IgG-ELISA" Composed of: 1. Tablet - 1 pc. 2. Calibration samples - 5 x 1.5 ml. 3. Control serum - 1 x 1.5 ml. 4. Conjugate - 1 x 14 ml. 5. ELISA Buffer - 1 x 50 ml. 6. Tetramethylbenzidine (TMB) substrate solution - 1 x 14 ml. 7. Washing solution concentrate - 1 x 22 ml. 8. Stop reagent - 1 x 14 ml. 9. Paper for gluing tablet - 2 pcs. 10. Instructions for use - 1 pc. 11. 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 2023/21476 and manufactured by HEMA LLC. The device was registered on November 03, 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.

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Class 2b
РЗН 2023/21476
Reagent kit for enzyme-linked immunosorbent assay of IgG antigens to Cytomegalovirus antigens in blood serum (plasma) "Cytomegalovirus IgG-ELISA" Composed of: 1. Tablet - 1 pc. 2. Calibration samples - 5 x 1.5 ml. 3. Control serum - 1 x 1.5 ml. 4. Conjugate - 1 x 14 ml. 5. ELISA Buffer - 1 x 50 ml. 6. Tetramethylbenzidine (TMB) substrate solution - 1 x 14 ml. 7. Washing solution concentrate - 1 x 22 ml. 8. Stop reagent - 1 x 14 ml. 9. Paper for gluing tablet - 2 pcs. 10. Instructions for use - 1 pc. 11. Quality control passport (analytical passport) - 1 pc.
Набор реагентов для иммуноферментного определения IgG антител к антигенам Cytomegalovirus в сыворотке (плазме) крови "Cytomegalovirus IgG-ИФА" в составе: 1. Планшет - 1 шт. 2. Калибровочные пробы - 5 х 1,5 мл. 3. Контрольная сыворотка - 1 х 1,5 мл. 4. Конъюгат - 1 х 14 мл. 5. ИФА-Буфер - 1 х 50 мл. 6. Субстратный раствор тетраметилбензидина (ТМБ) - 1 x 14 мл. 7. Концентрат отмывочного раствора - 1 х 22 мл. 8. Стоп-реагент - 1 х 14 мл. 9. Бумага для заклеивания планшет - 2 шт. 10. Инструкция по применению - 1 шт. 11. Паспорт контроля качества (аналитический паспорт) - 1 шт.
Roszdravnadzor Registration Number: РЗН 2023/21476
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Device Information
Device Name (English)
Reagent kit for enzyme-linked immunosorbent assay of IgG antigens to Cytomegalovirus antigens in blood serum (plasma) "Cytomegalovirus IgG-ELISA" Composed of: 1. Tablet - 1 pc. 2. Calibration samples - 5 x 1.5 ml. 3. Control serum - 1 x 1.5 ml. 4. Conjugate - 1 x 14 ml. 5. ELISA Buffer - 1 x 50 ml. 6. Tetramethylbenzidine (TMB) substrate solution - 1 x 14 ml. 7. Washing solution concentrate - 1 x 22 ml. 8. Stop reagent - 1 x 14 ml. 9. Paper for gluing tablet - 2 pcs. 10. Instructions for use - 1 pc. 11. Quality control passport (analytical passport) - 1 pc.
Device Name (Russian)
Набор реагентов для иммуноферментного определения IgG антител к антигенам Cytomegalovirus в сыворотке (плазме) крови "Cytomegalovirus IgG-ИФА" в составе: 1. Планшет - 1 шт. 2. Калибровочные пробы - 5 х 1,5 мл. 3. Контрольная сыворотка - 1 х 1,5 мл. 4. Конъюгат - 1 х 14 мл. 5. ИФА-Буфер - 1 х 50 мл. 6. Субстратный раствор тетраметилбензидина (ТМБ) - 1 x 14 мл. 7. Концентрат отмывочного раствора - 1 х 22 мл. 8. Стоп-реагент - 1 х 14 мл. 9. Бумага для заклеивания планшет - 2 шт. 10. Инструкция по применению - 1 шт. 11. Паспорт контроля качества (аналитический паспорт) - 1 шт.
Device Type (English)
N/A
Device Type (Russian)
217520
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
73636.0
Registration Number
РЗН 2023/21476
Registration Date
November 03, 2023
Manufacturer Information
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