Lidlab Amur DHEA-S reagent kit for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma by immunochemiluminescence assay (ICLA) using the Lidlab Amur automatic chemiluminescent analyzer for in vitro diagnostics according to TU 21.20.23-237-65614693-2022 Options: I. A set of reagents for 100 tests, consisting of: 1. Cartridge (containing; Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 2 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 1 pc. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 1 pc. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 1 pc. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 1 pc. 6. Vapor barrier covers - 8 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. II. Reagent kit for 200 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 4 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 2 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 2 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 2 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 2 pcs. 6. Vapor barrier hooks - 16 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. III. Reagent kit for 500 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 10 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 5 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 5 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 5 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 5 pcs. 6. Vapor barrier hooks - 40 pcs. 7. Instructions for use - 1 pc. 8. Analytical data sheet ~ 1 pc. IV. Reagent kit for 1000 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 20 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 10 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 10 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 10 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 10 pcs. 6. Vapor barrier hooks - 80 pcs. 7. Instructions for use - 1 pc.; 8. Analytical passport - 1 pc.
Russia·148880·LIDKOR LLC·Registered May 29, 2024·Class 2a- Device Name (English)
- Lidlab Amur DHEA-S reagent kit for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma by immunochemiluminescence assay (ICLA) using the Lidlab Amur automatic chemiluminescent analyzer for in vitro diagnostics according to TU 21.20.23-237-65614693-2022 Options: I. A set of reagents for 100 tests, consisting of: 1. Cartridge (containing; Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 2 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 1 pc. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 1 pc. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 1 pc. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 1 pc. 6. Vapor barrier covers - 8 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. II. Reagent kit for 200 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 4 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 2 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 2 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 2 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 2 pcs. 6. Vapor barrier hooks - 16 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. III. Reagent kit for 500 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 10 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 5 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 5 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 5 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 5 pcs. 6. Vapor barrier hooks - 40 pcs. 7. Instructions for use - 1 pc. 8. Analytical data sheet ~ 1 pc. IV. Reagent kit for 1000 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 20 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 10 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 10 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 10 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 10 pcs. 6. Vapor barrier hooks - 80 pcs. 7. Instructions for use - 1 pc.; 8. Analytical passport - 1 pc.
- Device Name (Russian)
- Набор реагентов "Лидлаб Амур ДГЭА-С" для количественного определения дегидроэпиандростерон-сульфата (ДГЭА-С, DHEA-S) в сыворотке и плазме крови человека методом иммунохемилюминесцентного анализа (ИХЛА) на анализаторе автоматическом иммунохемилюминесцентном "Лидлаб Амур" для диагностики in vitro по ТУ 21.20.23-237-65614693-2022 , варианты исполнения: I. Набор реагентов на 100 тестов, в составе: 1. Картридж (в составе; Реагент парамагнитных микрочастиц (R1) 3,5 мл/уп.; Реагент меченого ДГЭА-С (R2) 4,0 мл/уп.) - 2 шт. 2. Калибратор 1 (CAL1), лиофилизированный, 1,0 мл/флакон - 1 шт. 3. Калибратор 2 (CAL2), лиофилизированный, 1,0 мл/флакон - 1 шт. 4. Калибратор 3 (CAL3), лиофилизированный, 1,0 мл/флакон - 1 шт. 5. Калибратор 4 (CAL4), лиофилизированный, 1,0 мл/флакон - 1 шт. 6. Пароизоляционные крышки - 8 шт. 7. Инструкция по применению - 1 шт. 8. Аналитический паспорт - 1 шт. II. Набор реагентов на 200 тестов, в составе: 1. Картридж (в составе: Реагент парамагнитных микрочастиц (R1) 3,5 мл/уп.; Реагент меченого ДГЭА-С (R2) 4,0 мл/уп.) - 4 шт. 2. Калибратор 1 (CAL1), лиофилизированный, 1,0 мл/флакон - 2 шт. 3. Калибратор 2 (CAL2), лиофилизированный, 1,0 мл/флакон - 2 шт. 4. Калибратор 3 (CAL3), лиофилизированный, 1,0 мл/флакон - 2 шт. 5. Калибратор 4 (CAL4), лиофилизированный, 1,0 мл/флакон - 2 шт. 6. Пароизоляционные крьппки - 16 шт. 7. Инструкция по применению - 1 шт. 8. Аналитический паспорт - 1 шт. III. Набор реагентов на 500 тестов, в составе: 1. Картридж (в составе: Реагент парамагнитных микрочастиц (R1) 3,5 мл/уп.; Реагент меченого ДГЭА-С (R2) 4,0 мл/уп.) - 10 шт. 2. Калибратор 1 (CAL1), лиофилизированный, 1,0 мл/флакон - 5 шт. 3. Калибратор 2 (CAL2), лиофилизированный, 1,0 мл/флакон - 5 шт. 4. Калибратор 3 (CAL3), лиофилизированный, 1,0 мл/флакон - 5 шт. 5. Калибратор 4 (CAL4), лиофилизированный, 1,0 мл/флакон - 5 шт. 6. Пароизоляционные крьппки - 40 шт. 7. Инструкция по применению - 1 шт. 8. Аналитический паспорт ~ 1 шт. IV. Набор реагентов на 1000 тестов, в составе: 1. Картридж (в составе: Реагент парамагнитных микрочастиц (R1) 3,5 мл/уп.; Реагент меченого ДГЭА-С (R2) 4,0 мл/уп.) - 20 шт. 2. Калибратор 1 (CAL1), лиофилизированный, 1,0 мл/флакон - 10 шт. 3. Калибратор 2 (CAL2), лиофилизированный, 1,0 мл/флакон - 10 шт. 4. Калибратор 3 (CAL3), лиофилизированный, 1,0 мл/флакон - 10 шт. 5. Калибратор 4 (CAL4), лиофилизированный, 1,0 мл/флакон - 10 шт. 6. Пароизоляционные крьппки - 80 шт. 7. Инструкция по применению - 1 шт.; 8. Аналитический паспорт - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 148880
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78679.0
- Registration Number
- РЗН 2024/22777
- Registration Date
- May 29, 2024
- Manufacturer Name (English)
- LIDKOR LLC
- Manufacturer Name (Russian)
- ООО "ЛИДКОР"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. LIDKOR LLC, 15 Krasnodarskaya St., Yekaterinburg, 620033, Sverdlovsk Region, Russia. 2. LIDKOR LLC, 3A, Priborostroiteley St., Dubna, 141981, Moscow Region, Russia.
- Legal Address (Russian)
- 1. ООО "ЛИДКОР", Россия, 620033, Свердловская область, г. Екатеринбург, ул. Краснодарская, д. 15. 2. ООО "ЛИДКОР", Россия, 141981, Московская область, г. Дубна, ул. Приборостроителей, д. 3А.
- Manufacturing Address
- 620102, Россия, Свердловская область, г.о. город Екатеринбург, г. Екатеринбург, ул. Посадская, стр. 23, офис 204
Access comprehensive regulatory information for Lidlab Amur DHEA-S reagent kit for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma by immunochemiluminescence assay (ICLA) using the Lidlab Amur automatic chemiluminescent analyzer for in vitro diagnostics according to TU 21.20.23-237-65614693-2022 Options: I. A set of reagents for 100 tests, consisting of: 1. Cartridge (containing; Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 2 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 1 pc. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 1 pc. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 1 pc. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 1 pc. 6. Vapor barrier covers - 8 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. II. Reagent kit for 200 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 4 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 2 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 2 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 2 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 2 pcs. 6. Vapor barrier hooks - 16 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. III. Reagent kit for 500 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 10 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 5 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 5 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 5 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 5 pcs. 6. Vapor barrier hooks - 40 pcs. 7. Instructions for use - 1 pc. 8. Analytical data sheet ~ 1 pc. IV. Reagent kit for 1000 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1) 3.5 ml/pack; Reagent of labeled DHEA-S (R2) 4.0 ml/pack) - 20 pcs. 2. Calibrator 1 (CAL1), lyophilized, 1.0 ml/vial - 10 pcs. 3. Calibrator 2 (CAL2), lyophilized, 1.0 ml/vial - 10 pcs. 4. Calibrator 3 (CAL3), lyophilized, 1.0 ml/vial - 10 pcs. 5. Calibrator 4 (CAL4), lyophilized, 1.0 ml/vial - 10 pcs. 6. Vapor barrier hooks - 80 pcs. 7. Instructions for use - 1 pc.; 8. Analytical passport - 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 2024/22777 and manufactured by LIDKOR LLC. The device was registered on May 29, 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.