Reagent kit for simultaneous detection of antibodies to human immunodeficiency viruses types 1 and 2 (HIV-1 and HIV-2), HIV-1 group O and HIV-1 p24 antigen by enzyme-linked immunosorbent assay, version 2.0 (DS-ELISA-HIV-AGATE-SCREEN 2.0) according to TU 9398-232-05941003-2016 Options: I. Set 1 is designed for 96 (one collapsible plate) determinations, including Control; is designed for both manual setting and placement on open-type ELISA analyzers with the possibility of fractional use, consisting of: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 1 tablet. 2. Conjugate-1 -1 vial. (1.2 ml). 3. Conjugate-2 - 1 vial. (2.5 ml). 4. RRB-1 - solution for dilution of Conjugate-1 - 1 vial. (12.0 ml). 5. RRB-2 - solution for dilution of Conjugate-2 - 1 vial. (25.0 ml). 6. K+Ab - control positive sample containing antibodies to HIV - 1 vial. (2.0 ml). 7. K+Ag - control positive sample containing artificial antigen p24 HIV1 - 1 vial. (2.0 ml). 8. K- - control negative sample, inactivated - 1 fl. (2.5 ml). 9. PR - flushing solution - 1 fl. (50.0 ml). 10. Stop-reagent - 1 bottle. (25.0 ml). 11. SB - substrate buffer solution - 1 fl. (25.0 ml). 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine - 1 fl. (2.5 ml). 13. Protective films for ELISA plates - 2 pcs. 14. Disposable tips - 16 pcs. 15. Plastic trays for liquid reagents - 2 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bag with Zip-Lock: 1 pc II. Set 2 is designed for 192 (two collapsible plates) determinations, including Control; designed for both manual staging with the possibility of fractional use, and for simultaneous installation on open-type ELISA analyzers, consisting of: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 2 plates. 2. Conjugate-1 - 1 vial. (1.2 ml). 3. Conjugate-2 - 1 vial. (2.5 ml). 4. RRB-1 - solution for dilution of Conjugate-1 - 1 vial. (12.0 ml). 5. RRB-2 - solution for dilution of Conjugate-2 - 1 vial. (25.0 ml). 6. K+AT - control positive sample containing antibodies to HIV - I fl, (2.0 ml). 7. K+Ag - control positive sample containing artificial HIV-1 p24 antigen - 1 fl. (2.0 ml). 8. K- - control negative sample - 1 fl. (2.5 ml). 9. PR - flushing solution - 1 fl. (120.0 ml). 10. Stop-reagent - 2 bottles. 25.0 ml. 11. SB - substrate buffer solution - 1 fl. (25.0 ml). 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine: 1 vial. (2.5 ml). 13. Protective films for ELISA plates - 4 pcs. 14. Disposable tips - 32 pcs. 15. Plastic trays for liquid reagents - 4 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bags with Zip-Lock lock - 2 pcs. III. Set 3 is designed to carry out 480 (five collapsible plates) determinations, including controls; designed for both manual staging with the possibility of fractional and for simultaneous use on open-type ELISA analyzers, in Composition: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 5 plates. 2. Conjugate-1 - 1 vial. 3.6 ml or 3 vials. 1.2 ml. 3. Conjugate-2 - 3 vials. 2.5 ml. 4. RRB-1 - solution for dilution of Conjugate-1 - 3 vials. 12.0 ml. 5. RRB-2 - solution for dilution of Conjugate-2 - 3 vials. 25.0 ml. 6. K+AT - control positive sample - 1 vial. 4.0 ml or 2 vials. 2.0 ml. 7. K+AG - control positive sample - 1 vial. 4.0 ml or 2 vials. 2.0 ml. 8. K- - control negative sample - 1 fl. 5.0 ml or 2 vials. 2.5 ml. 9. PR - flushing solution - 2 fl. 120.0 ml. 10. Stop-reagent - 2 bottles. 50.0 ml or 4 vials. 25.0 ml. 11. SB - substrate buffer solution - 2 fl. 50.0 ml or 3 vials. 25.0 ml. 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine - 2 vials. 3.5 ml or 3 vials. 2.5 ml. 13. Protective films for ELISA plates - 10 pcs. 14. Disposable tips - 80 pcs. 15. Plastic baths for liquid reagents - 10 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bags with Zip-Lock lock - 3 pcs.
Russia·110110·LLC "NPO "Diagnostic Systems"·Registered April 27, 2023·N/A- Device Name (English)
- Reagent kit for simultaneous detection of antibodies to human immunodeficiency viruses types 1 and 2 (HIV-1 and HIV-2), HIV-1 group O and HIV-1 p24 antigen by enzyme-linked immunosorbent assay, version 2.0 (DS-ELISA-HIV-AGATE-SCREEN 2.0) according to TU 9398-232-05941003-2016 Options: I. Set 1 is designed for 96 (one collapsible plate) determinations, including Control; is designed for both manual setting and placement on open-type ELISA analyzers with the possibility of fractional use, consisting of: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 1 tablet. 2. Conjugate-1 -1 vial. (1.2 ml). 3. Conjugate-2 - 1 vial. (2.5 ml). 4. RRB-1 - solution for dilution of Conjugate-1 - 1 vial. (12.0 ml). 5. RRB-2 - solution for dilution of Conjugate-2 - 1 vial. (25.0 ml). 6. K+Ab - control positive sample containing antibodies to HIV - 1 vial. (2.0 ml). 7. K+Ag - control positive sample containing artificial antigen p24 HIV1 - 1 vial. (2.0 ml). 8. K- - control negative sample, inactivated - 1 fl. (2.5 ml). 9. PR - flushing solution - 1 fl. (50.0 ml). 10. Stop-reagent - 1 bottle. (25.0 ml). 11. SB - substrate buffer solution - 1 fl. (25.0 ml). 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine - 1 fl. (2.5 ml). 13. Protective films for ELISA plates - 2 pcs. 14. Disposable tips - 16 pcs. 15. Plastic trays for liquid reagents - 2 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bag with Zip-Lock: 1 pc II. Set 2 is designed for 192 (two collapsible plates) determinations, including Control; designed for both manual staging with the possibility of fractional use, and for simultaneous installation on open-type ELISA analyzers, consisting of: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 2 plates. 2. Conjugate-1 - 1 vial. (1.2 ml). 3. Conjugate-2 - 1 vial. (2.5 ml). 4. RRB-1 - solution for dilution of Conjugate-1 - 1 vial. (12.0 ml). 5. RRB-2 - solution for dilution of Conjugate-2 - 1 vial. (25.0 ml). 6. K+AT - control positive sample containing antibodies to HIV - I fl, (2.0 ml). 7. K+Ag - control positive sample containing artificial HIV-1 p24 antigen - 1 fl. (2.0 ml). 8. K- - control negative sample - 1 fl. (2.5 ml). 9. PR - flushing solution - 1 fl. (120.0 ml). 10. Stop-reagent - 2 bottles. 25.0 ml. 11. SB - substrate buffer solution - 1 fl. (25.0 ml). 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine: 1 vial. (2.5 ml). 13. Protective films for ELISA plates - 4 pcs. 14. Disposable tips - 32 pcs. 15. Plastic trays for liquid reagents - 4 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bags with Zip-Lock lock - 2 pcs. III. Set 3 is designed to carry out 480 (five collapsible plates) determinations, including controls; designed for both manual staging with the possibility of fractional and for simultaneous use on open-type ELISA analyzers, in Composition: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 5 plates. 2. Conjugate-1 - 1 vial. 3.6 ml or 3 vials. 1.2 ml. 3. Conjugate-2 - 3 vials. 2.5 ml. 4. RRB-1 - solution for dilution of Conjugate-1 - 3 vials. 12.0 ml. 5. RRB-2 - solution for dilution of Conjugate-2 - 3 vials. 25.0 ml. 6. K+AT - control positive sample - 1 vial. 4.0 ml or 2 vials. 2.0 ml. 7. K+AG - control positive sample - 1 vial. 4.0 ml or 2 vials. 2.0 ml. 8. K- - control negative sample - 1 fl. 5.0 ml or 2 vials. 2.5 ml. 9. PR - flushing solution - 2 fl. 120.0 ml. 10. Stop-reagent - 2 bottles. 50.0 ml or 4 vials. 25.0 ml. 11. SB - substrate buffer solution - 2 fl. 50.0 ml or 3 vials. 25.0 ml. 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine - 2 vials. 3.5 ml or 3 vials. 2.5 ml. 13. Protective films for ELISA plates - 10 pcs. 14. Disposable tips - 80 pcs. 15. Plastic baths for liquid reagents - 10 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bags with Zip-Lock lock - 3 pcs.
- Device Name (Russian)
- Набор реагентов для одновременного выявления антител к вирусам иммунодефицита человека 1 и 2 типов (ВИЧ-1 и ВИЧ-2), ВИЧ-1 группы О и антигена р24 ВИЧ-1 методом иммуноферментного анализа, версия 2.0 (ДС-ИФА-ВИЧ-АГАТ-СКРИН 2.0) по ТУ 9398-232-05941003-2016 варианты исполнения: I. Комплект 1 рассчитан на проведение 96 (один разборный планшет) определений, включая контрольные; предназначен как для ручной постановки, так и для постановки на ИФА - анализаторах открытого типа с возможностью дробного использования, в составе: 1. Иммуносорбент - планшет полистироловый 96-луночный разборный до стрипов (или до лунок), в лунках которого сорбированы искусственные антигены - аналоги белков ВИЧ-1, ВИЧ-2, ВИЧ-1 группы О и антитела к антигену р24 ВИЧ-1 - 1 планшет. 2. Конъюгат-1 -1 фл. (1,2 мл). 3. Конъюгат-2 - 1 фл. (2,5 мл). 4. РРК-1 - раствор для разведения Конъюгата-1 - 1 фл. (12,0 мл). 5. РРК-2 - раствор для разведения Конъюгата-2 - 1 фл. (25,0 мл). 6. К+Ат - контрольный положительный образец, содержащий антитела к ВИЧ - 1 фл. (2,0 мл). 7. К+Аг - контрольный положительный образец, содержащий искусственный антиген р24 ВИЧ1 - 1 фл. (2,0 мл). 8. К- - контрольный отрицательный образец, инактивированный - 1 фл. (2,5 мл). 9. ПР - промывочный раствор - 1 фл. (50,0 мл). 10. Стоп-реагент - 1 фл. (25,0 мл). 11. СБ - субстратный буферный раствор - 1 фл. (25,0 мл). 12. ТМБ - раствор, содержащий 3,3',5,5'-тетраметилбензидин - 1 фл. (2,5 мл). 13. Плёнки защитные для ИФА-планшетов - 2 шт. 14. Наконечники одноразовые - 16 шт. 15. Ванночки пластиковые для жидких реагентов - 2 шт. 16. Инструкция по применению. 17. Паспорт. Принадлежности: 1. Пакет полиэтиленовый с замком Zip-Lock: 1 шт. II. Комплект 2 рассчитан на проведение 192 (два разборных планшета) определений, включая контрольные; предназначен как для ручной постановки с возможностью дробного использования, так и для одновременной постановки на ИФА-анализаторах открытого типа, в составе: 1. Иммуносорбент - планшет полистироловый 96-луночный разборный до стрипов (или до лунок), в лунках которого сорбированы искусственные антигены - аналоги белков ВИЧ-1, ВИЧ-2, ВИЧ-1 группы О и антитела к антигену р24 ВИЧ-1 - 2 планшета. 2. Конъюгат-1 - 1 фл. (1,2 мл). 3. Конъюгат-2 - 1 фл. (2,5 мл). 4. РРК-1 - раствор для разведения Конъюгата-1 - 1 фл. (12,0 мл). 5. РРК-2 - раствор для разведения Конъюгата-2 - 1 фл. (25,0 мл). 6. К+АТ - контрольный положительный образец, содержащий антитела к ВИЧ - I фл, (2,0 мл). 7. К+Аг - контрольный положительный образец, содержащий искусственный антиген р24 ВИЧ-1 - 1 фл. (2,0 мл). 8. К- - контрольный отрицательный образец -1 фл. (2,5 мл). 9. ПР - промывочный раствор - 1 фл. (120,0 мл). 10. Стоп-реагент - 2 фл. по 25,0 мл. 11. СБ - субстратный буферный раствор - 1 фл. (25,0 мл). 12. ТМБ - раствор, содержащий 3,3',5,5'-тетраметилбензидин: 1 фл. (2,5 мл). 13. Плёнки защитные для ИФА-планшетов - 4 шт. 14. Наконечники одноразовые - 32 шт. 15. Ванночки пластиковые для жидких реагентов - 4 шт. 16. Инструкция по применению. 17. Паспорт. Принадлежности: 1. Пакеты полиэтиленовые с замком Zip-Lock - 2 шт. III. Комплект 3 рассчитан на проведение 480 (пять разборных планшетов) определений, включая контрольные; предназначен как для ручной постановки с возможностью дробного использования, так и для одновременной постановки на ИФА-анализаторах открытого типа, в составе: 1. Иммуносорбент - планшет полистироловый 96-луночный разборный до стрипов (или до лунок), в лунках которого сорбированы искусственные антигены - аналоги белков ВИЧ-1, ВИЧ-2, ВИЧ-1 группы О и антитела к антигену р24 ВИЧ-1 - 5 планшетов. 2. Конъюгат-1 - 1 фл. 3,6 мл или 3 фл. по 1,2 мл. 3. Конъюгат-2 - 3 фл. по 2,5 мл. 4. РРК-1 - раствор для разведения Конъюгата-1 - 3 фл. по 12,0 мл. 5. РРК-2 - раствор для разведения Конъюгата-2 - 3 фл. по 25,0 мл. 6. К+АТ - контрольный положительный образец - 1 фл. 4,0 мл или 2 фл. по 2,0 мл. 7. К+АГ - контрольный положительный образец - 1 фл. 4,0 мл или 2 фл. по 2,0 мл. 8. К- - контрольный отрицательный образец - 1 фл. 5,0 мл или 2 фл. по 2,5 мл. 9. ПР - промывочный раствор - 2 фл. по 120,0 мл. 10. Стоп-реагент - 2 фл. по 50,0 мл или 4 фл. по 25,0 мл. 11. СБ - субстратный буферный раствор - 2 фл. по 50,0 мл или 3 фл. по 25,0 мл. 12. ТМБ - раствор, содержащий 3,3',5,5'-тетраметилбензидин - 2 фл. по 3,5 мл или 3 фл. по 2,5 мл. 13. Плёнки защитные для ИФА-планшетов - 10 шт. 14. Наконечники одноразовые - 80 шт. 15. Ванночки пластиковые для жидких реагентов - 10 шт. 16. Инструкция по применению. 17. Паспорт. Принадлежности: 1. Пакеты полиэтиленовые с замком Zip-Lock - 3 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 110110
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 70846.0
- Registration Number
- РЗН 2018/6903
- Registration Date
- April 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 simultaneous detection of antibodies to human immunodeficiency viruses types 1 and 2 (HIV-1 and HIV-2), HIV-1 group O and HIV-1 p24 antigen by enzyme-linked immunosorbent assay, version 2.0 (DS-ELISA-HIV-AGATE-SCREEN 2.0) according to TU 9398-232-05941003-2016 Options: I. Set 1 is designed for 96 (one collapsible plate) determinations, including Control; is designed for both manual setting and placement on open-type ELISA analyzers with the possibility of fractional use, consisting of: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 1 tablet. 2. Conjugate-1 -1 vial. (1.2 ml). 3. Conjugate-2 - 1 vial. (2.5 ml). 4. RRB-1 - solution for dilution of Conjugate-1 - 1 vial. (12.0 ml). 5. RRB-2 - solution for dilution of Conjugate-2 - 1 vial. (25.0 ml). 6. K+Ab - control positive sample containing antibodies to HIV - 1 vial. (2.0 ml). 7. K+Ag - control positive sample containing artificial antigen p24 HIV1 - 1 vial. (2.0 ml). 8. K- - control negative sample, inactivated - 1 fl. (2.5 ml). 9. PR - flushing solution - 1 fl. (50.0 ml). 10. Stop-reagent - 1 bottle. (25.0 ml). 11. SB - substrate buffer solution - 1 fl. (25.0 ml). 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine - 1 fl. (2.5 ml). 13. Protective films for ELISA plates - 2 pcs. 14. Disposable tips - 16 pcs. 15. Plastic trays for liquid reagents - 2 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bag with Zip-Lock: 1 pc II. Set 2 is designed for 192 (two collapsible plates) determinations, including Control; designed for both manual staging with the possibility of fractional use, and for simultaneous installation on open-type ELISA analyzers, consisting of: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 2 plates. 2. Conjugate-1 - 1 vial. (1.2 ml). 3. Conjugate-2 - 1 vial. (2.5 ml). 4. RRB-1 - solution for dilution of Conjugate-1 - 1 vial. (12.0 ml). 5. RRB-2 - solution for dilution of Conjugate-2 - 1 vial. (25.0 ml). 6. K+AT - control positive sample containing antibodies to HIV - I fl, (2.0 ml). 7. K+Ag - control positive sample containing artificial HIV-1 p24 antigen - 1 fl. (2.0 ml). 8. K- - control negative sample - 1 fl. (2.5 ml). 9. PR - flushing solution - 1 fl. (120.0 ml). 10. Stop-reagent - 2 bottles. 25.0 ml. 11. SB - substrate buffer solution - 1 fl. (25.0 ml). 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine: 1 vial. (2.5 ml). 13. Protective films for ELISA plates - 4 pcs. 14. Disposable tips - 32 pcs. 15. Plastic trays for liquid reagents - 4 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bags with Zip-Lock lock - 2 pcs. III. Set 3 is designed to carry out 480 (five collapsible plates) determinations, including controls; designed for both manual staging with the possibility of fractional and for simultaneous use on open-type ELISA analyzers, in Composition: 1. Immunosorbent - 96-well collapsible polystyrene plate up to strips (or up to wells), in the wells of which artificial antigens are sorbed - analogues of HIV-1, HIV-2 proteins, HIV-1 group O and antibodies to HIV-1 p24 antigen - 5 plates. 2. Conjugate-1 - 1 vial. 3.6 ml or 3 vials. 1.2 ml. 3. Conjugate-2 - 3 vials. 2.5 ml. 4. RRB-1 - solution for dilution of Conjugate-1 - 3 vials. 12.0 ml. 5. RRB-2 - solution for dilution of Conjugate-2 - 3 vials. 25.0 ml. 6. K+AT - control positive sample - 1 vial. 4.0 ml or 2 vials. 2.0 ml. 7. K+AG - control positive sample - 1 vial. 4.0 ml or 2 vials. 2.0 ml. 8. K- - control negative sample - 1 fl. 5.0 ml or 2 vials. 2.5 ml. 9. PR - flushing solution - 2 fl. 120.0 ml. 10. Stop-reagent - 2 bottles. 50.0 ml or 4 vials. 25.0 ml. 11. SB - substrate buffer solution - 2 fl. 50.0 ml or 3 vials. 25.0 ml. 12. TMB - solution containing 3,3',5,5'-tetramethylbenzidine - 2 vials. 3.5 ml or 3 vials. 2.5 ml. 13. Protective films for ELISA plates - 10 pcs. 14. Disposable tips - 80 pcs. 15. Plastic baths for liquid reagents - 10 pcs. 16. Instructions for use. 17. Passport. Accessories: 1. Plastic bags with Zip-Lock lock - 3 pcs. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2018/6903 and manufactured by LLC "NPO "Diagnostic Systems". The device was registered on April 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.