Lidlab Amur free T4 reagent kit for quantitative determination of free thyroxine (free T4, fT4) in human serum and plasma by immunochemiluminescence assay (ICLA) using the Lidlab Amur automatic chemiluminescence analyzer for in vitro diagnostics according to TU 21.20.23-228-65614693-2022 In versions: I. A set of reagents for 100 tests, consisting of: 1. Cartridge (containing: Paramagnetic microparticles reagent (R1), 3.5 ml/pack; Conjugate reagent (R2), 4.0 ml/pack) - 2 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 1 pc. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 1 pc. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 1 pc. 5. Calibrator 4 (CAL4), 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-conjugate (R2), 4.0 ml/pack) - 4 pcs. 2. Calibrator 1 (CALI), 1.0 ml/vial - 2 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 2 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 2 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 2 pcs. 6. Vapor barrier covers - 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-conjugate (R2), 4.0 ml/pack) - 10 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 5 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 5 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 5 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 5 pcs. 6. Vapor barrier covers - 40 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. IV. Reagent kit for 1000 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1), 3.5 ml/pack; Reagent-conjugate (R2), 4.0 ml/pack) - 20 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 10 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 10 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 10 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 10 pcs. 6. Vapor barrier covers - 80 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc.
Russia·108420·LIDKOR LLC·Registered June 07, 2024·Class 2a- Device Name (English)
- Lidlab Amur free T4 reagent kit for quantitative determination of free thyroxine (free T4, fT4) in human serum and plasma by immunochemiluminescence assay (ICLA) using the Lidlab Amur automatic chemiluminescence analyzer for in vitro diagnostics according to TU 21.20.23-228-65614693-2022 In versions: I. A set of reagents for 100 tests, consisting of: 1. Cartridge (containing: Paramagnetic microparticles reagent (R1), 3.5 ml/pack; Conjugate reagent (R2), 4.0 ml/pack) - 2 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 1 pc. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 1 pc. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 1 pc. 5. Calibrator 4 (CAL4), 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-conjugate (R2), 4.0 ml/pack) - 4 pcs. 2. Calibrator 1 (CALI), 1.0 ml/vial - 2 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 2 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 2 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 2 pcs. 6. Vapor barrier covers - 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-conjugate (R2), 4.0 ml/pack) - 10 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 5 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 5 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 5 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 5 pcs. 6. Vapor barrier covers - 40 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. IV. Reagent kit for 1000 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1), 3.5 ml/pack; Reagent-conjugate (R2), 4.0 ml/pack) - 20 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 10 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 10 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 10 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 10 pcs. 6. Vapor barrier covers - 80 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc.
- Device Name (Russian)
- Набор реагентов "Лидлаб Амур свободный Т4" для количественного определения свободного тироксина (свободный Т4, fТ4) в сыворотке и плазме крови человека методом иммунохемилюминесцентного анализа (ИХЛА) на анализаторе автоматическом иммунохемилюминесцентном "Лидлаб Амур" для диагностики in vitro по ТУ 21.20.23-228-65614693-2022 в вариантах исполнения: I. Набор реагентов на 100 тестов, в составе: 1. Картридж (в составе: Реагент парамагнитных микрочастиц (R1), 3,5 мл/уп.; Реагент-конъюгат (R2), 4,0 мл/уп.) - 2 шт. 2. Калибратор 1 (CAL1), 1,0 мл/флакон - 1 шт. 3. Калибратор 2 (CAL2), 1,0 мл/флакон - 1 шт. 4. Калибратор 3 (CAL3), 1,0 мл/флакон - 1 шт. 5. Калибратор 4 (CAL4), 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-конъюгат (R2), 4,0 мл/уп.) - 4 шт. 2. Калибратор 1 (CALI), 1,0 мл/флакон - 2 шт. 3. Калибратор 2 (CAL2), 1,0 мл/флакон - 2 шт. 4. Калибратор 3 (CAL3), 1,0 мл/флакон - 2 шт. 5. Калибратор 4 (CAL4), 1,0 мл/флакон - 2 шт. 6. Пароизоляционные крышки - 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-конъюгат (R2), 4,0 мл/уп.) - 10 шт. 2. Калибратор 1 (CAL1), 1,0 мл/флакон - 5 шт. 3. Калибратор 2 (CAL2), 1,0 мл/флакон - 5 шт. 4. Калибратор 3 (CAL3), 1,0 мл/флакон - 5 шт. 5. Калибратор 4 (CAL4), 1,0 мл/флакон - 5 шт. 6. Пароизоляционные крышки - 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-конъюгат (R2), 4,0 мл/уп.) - 20 шт. 2. Калибратор 1 (CAL1), 1,0 мл/флакон - 10 шт. 3. Калибратор 2 (CAL2), 1,0 мл/флакон - 10 шт. 4. Калибратор 3 (CAL3), 1,0 мл/флакон - 10 шт. 5. Калибратор 4 (CAL4), 1,0 мл/флакон - 10 шт. 6. Пароизоляционные крышки - 80 шт. 7. Инструкция по применению - 1 шт. 8. Аналитический паспорт - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 108420
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78399.0
- Registration Number
- РЗН 2024/22877
- Registration Date
- June 07, 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 free T4 reagent kit for quantitative determination of free thyroxine (free T4, fT4) in human serum and plasma by immunochemiluminescence assay (ICLA) using the Lidlab Amur automatic chemiluminescence analyzer for in vitro diagnostics according to TU 21.20.23-228-65614693-2022 In versions: I. A set of reagents for 100 tests, consisting of: 1. Cartridge (containing: Paramagnetic microparticles reagent (R1), 3.5 ml/pack; Conjugate reagent (R2), 4.0 ml/pack) - 2 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 1 pc. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 1 pc. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 1 pc. 5. Calibrator 4 (CAL4), 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-conjugate (R2), 4.0 ml/pack) - 4 pcs. 2. Calibrator 1 (CALI), 1.0 ml/vial - 2 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 2 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 2 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 2 pcs. 6. Vapor barrier covers - 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-conjugate (R2), 4.0 ml/pack) - 10 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 5 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 5 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 5 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 5 pcs. 6. Vapor barrier covers - 40 pcs. 7. Instructions for use - 1 pc. 8. Analytical passport - 1 pc. IV. Reagent kit for 1000 tests, consisting of: 1. Cartridge (containing: Reagent of paramagnetic microparticles (R1), 3.5 ml/pack; Reagent-conjugate (R2), 4.0 ml/pack) - 20 pcs. 2. Calibrator 1 (CAL1), 1.0 ml/vial - 10 pcs. 3. Calibrator 2 (CAL2), 1.0 ml/vial - 10 pcs. 4. Calibrator 3 (CAL3), 1.0 ml/vial - 10 pcs. 5. Calibrator 4 (CAL4), 1.0 ml/vial - 10 pcs. 6. Vapor barrier covers - 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 2024/22877 and manufactured by LIDKOR LLC. The device was registered on June 07, 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.