BERNARDO LEW E HIJOS SRL. - Authorized Company Profile | Argentina ANMAT

Anti-HBs, Anti-HBc and Anti-HBc IgM are used as an aid in the diagnosis of Hepatitis B Virus (HBV) infection

Anti-HBs, Anti-HBc y Anti-HBc IgM se utilizan como ayuda en el diagnóstico de la infección por el Virus de la Hepatitis B (VHB)

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Registration of products for IVD diagnostics - Group C and DJul 19, 2024

Mindray Brand Analyzers: 1)Sample processing system model: NEW CAL 8000; Composed of the analyzer Model BC-6800Plus Automated Hematology Analyzer and/or Automated Protein C Analyzer reagent model CRP-M100 (including accessories: CRP CLEANER) 2)Automated hematology analyzer; Model No.: BC-5310 CRP Consumables: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser

Analizadores marca Mindray: 1)Sistema de procesamiento de muestras modelo: NEW CAL 8000; Compuesto por el analizador hematológico automatizado modelo BC-6800Plus y/o el analizador automatizado de proteína C reactiva modelo CRP-M100 (incluyendo accesorios: LIMPIADOR CRP) 2)Analizador hematológico automatizado; Modelo: BC-5310 CRP Consumibles: M-6DR DILUENT; DS DILUENT; M-6LD LYSE; M-6LN LYSE; M-6LH LYSE; M-6FN DYE; M-6FR DYE; M-6FD DYE; SC-CAL PLUS; Probe Cleanser

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IVD Modification Group A and BJun 12, 2024

The Chagas assay is used as an aid in the diagnosis of Chagas disease

El ensayo Chagas es utilizado como ayuda en el diagnóstico de la enfermedad de Chagas

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Registration of products for IVD diagnostics - Group C and DJun 06, 2024

D-Dimer Kit (DD); Prothrombin Time kit (PT); Activated Partial Thromboplastin Time Kit (APTT); Antithrombin Kit (AT); Coagulation Control; Fibrinogen Calibrator; Fibrinogen Degradation Product Kit (FDP) ; Fibrinogen Reagent Kit (FIB); Thrombin Time kit (TT); SFT-Special Cleaning Liquid; SFW-Cleaning Liquid

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Registration of products for IVD diagnostics - Group C and DApr 29, 2024

1) Auto Slider Maker & Stainer 2) Automated Digital Cell Morphology Analyzer

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IVD Registration Group A and BApr 11, 2024

Finecare One Step c Tn T Rapid Quantitative Test

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Registration of products for IVD diagnostics - Group C and DMar 13, 2024

EQUIPOS: • Fully Automated Coagulation Analyzer • Semi Automated Coagulation Analyzer • Automated ERS Analyzer • Semi-Automated Coagulation Analyzer Cuvette • Automated Coagulation Analyzer Cuvette

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IVD Registration Group A and BFeb 28, 2024

Microscope Slides

Microscope Slides (Portaobjetos para microscopios)

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IVD Registration Group A and BFeb 09, 2024

Equipos: Fully-auto chemiluminescence immunoassay analyzer Consumibles: Reaction Module; Starter 1+2; Wash Concentrate; Light Check; System Tubing Cleaning Solution

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IVD Modification Group A and BFeb 05, 2024

AXINEA SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test

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IVD Registration Group A and BJan 19, 2024

The Free ß-HCG and PAPP-A assays are used to detect congenital disorders during the first trimester of pregnancy

Los ensayos Free ß-HCG y PAPP-A son utilizados para detectar trastornos congénitos durante el primer trimestre de embarazo

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Registration of products for IVD diagnostics - Group C and DDec 21, 2023

1. MAGLUMI DIRECT RENIN (CLIA) 2. MAGLUMI ALDOSTERONE (CLIA) 3. MAGLUMI ANGIOTENSIN I (CLIA) 4. MAGLUMI ANGIOTENSIN II (CLIA) 5. MAGLUMI CORTISOL (CLIA) 6. MAGLUMI ACTH (CLIA) 7. ALBUMIN (CLIA) 8. MAGLUMI DIRECT RENIN (CLIA) CONTROLS 9. MAGLUMI ALDOSTERONE (CLIA) CONTROLS 10. MAGLUMI ANGIOTENSIN I (CLIA) CONTROLS 11. MAGLUMI ANGIOTENSIN II (CLIA) CONTROLS 12. MAGLUMI CORTISOL (CLIA) CONTROLS 13. MAGLUMI ACTH (CLIA) CONTROLS 14. MAGLUMI ALBUMIN (CLIA) CONTROLS

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IVD Registration Group A and BOct 24, 2023

MAGLUMI HIV Ab/Ag Combi (CLIA)

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Registration of products for IVD diagnostics - Group C and DOct 10, 2023

1. MAGLUMI C-PEPTIDE (CLIA) 2. MAGLUMI INSULIN (CLIA) 3. MAGLUMI ANTI-GAD (CLIA) 4. MAGLUMI ANTI-IA2 (CLIA) 5. MAGLUMI ICA (CLIA) 6. MAGLUMI IAA (CLIA) 7. MAGLUMI PROINSULIN (CLIA) 8. MAGLUMI C-PEPTIDE (CLIA) CONTROLS 9. MAGLUMI INSULIN (CLIA) CONTROLS 10. MAGLUMI ANTI-GAD (CLIA) CONTROLS 11. MAGLUMI ANTI-IA2 (CLIA) CONTROLS 12. MAGLUMI ICA (CLIA) CONTROLS 13. MAGLUMI IAA (CLIA) CONTROLS 14. MAGLUMI PROINSULIN (CLIA) CONTROLS

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IVD Registration Group A and BSep 25, 2023

1. MAGLUMI HYALURONIC ACID (CLIA) 2. MAGLUMI PIIIP N-P (CLIA) 3. MAGLUMI COL IV (CLIA) 4. MAGLUMI LAMININ (CLIA) 5. MAGLUMI CHOLYGLYCINE (CLIA) 6. MAGLUMI GP73 (CLIA) 7. MAGLUMI SERUM AMYLOID A (CLIA) 8. MAGLUMI TNF-a (CLIA) 9. MAGLUMI IL-6 (CLIA) 10. MAGLUMI HYALURONIC ACID (CLIA) CONTROLS 11. MAGLUMI PIIIP N-P (CLIA) CONTROLS 12. MAGLUMI COL IV (CLIA) CONTROLS 13. MAGLUMI LAMININ (CLIA) CONTROLS 14. MAGLUMI CHOLYGLYCINE (CLIA) CONTROLS 15. MAGLUMI GP73 (CLIA) CONTROLS 16. MAGLUMI SERUM AMYLOID A (CLIA) CONTROLS 17. MAGLUMI TNF-a (CLIA) CONTROLS 18. MAGLUMI IL-6 (CLIA) CONTROLS

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IVD Registration Group A and BSep 13, 2023

1. Finecare™ FIA Meter III Plus 2. Finecare™ IL-6 Rapid Quantitative Test

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IVD Registration Group A and BSep 05, 2023

1. MAGLUMI ANTI CCP (CLIA) 2. MAGLUMI ANTI DSDNA (CLIA) 3. MAGLUMI ANA SCREEN (CLIA) 4. MAGLUMI ENA SCREEN (CLIA) 5. MAGLUMI ANTI SCL 70 IGG (CLIA) 6. MAGLUMI ANTI CENTROMERES IGG (CLIA) 7. MAGLUMI ANTIHISTONE IGG (CLIA) 8. MAGLUMI RIB P IGG (CLIA) 9. MAGLUMI SM IGG (CLIA) 10. MAGLUMI SS B IGG (CLIA) 11. MAGLUMI JO 1 IGG (CLIA) 12. MAGLUMI SM/RNP IGG (CLIA) 13. MAGLUMI SS A/RO IGG (CLIA) 14. MAGLUMI AMA M2 IGG (CLIA) 15. MAGLUMI ANTI CCP (CLIA) CONTROLS 16. MAGLUMI ANTI DSDNA (CLIA) CONTROLS 17. MAGLUMI ANA SCREEN (CLIA) CONTROLS 18. MAGLUMI ENA SCREEN (CLIA) CONTROLS 19. MAGLUMI ANTI SCL 70 IGG (CLIA) CONTROLS 20. MAGLUMI ANTI CENTROMERES IGG (CLIA) CONTROLS 21. MAGLUMI ANTIHISTONE IGG (CLIA) CONTROLS 22. MAGLUMI RIB P IGG (CLIA) CONTROLS 23. MAGLUMI SM IGG (CLIA) CONTROLS 24. MAGLUMI SS B IGG (CLIA) CONTROLS 25. MAGLUMI JO 1 IGG (CLIA) CONTROLS 26. MAGLUMI SM/RNP IGG (CLIA) CONTROLS 27. MAGLUMI SS A/RO IGG (CLIA) CONTROLS 28. MAGLUMI AMA M2 IGG (CLIA) CONTROLS

1. MAGLUMI ANTI CCP (CLIA) 2. MAGLUMI ANTI DSDNA (CLIA) 3. MAGLUMI ANA SCREEN (CLIA) 4. MAGLUMI ENA SCREEN (CLIA) 5. MAGLUMI ANTI SCL 70 IGG (CLIA) 6. MAGLUMI ANTI CENTROMERES IGG (CLIA) 7. MAGLUMI ANTI HISTONES IGG (CLIA) 8. MAGLUMI RIB P IGG (CLIA) 9. MAGLUMI SM IGG (CLIA) 10. MAGLUMI SS B IGG (CLIA) 11. MAGLUMI JO 1 IGG (CLIA) 12. MAGLUMI SM / RNP IGG (CLIA) 13. MAGLUMI SS A / RO IGG (CLIA) 14. MAGLUMI AMA M2 IGG (CLIA) 15. MAGLUMI ANTI CCP (CLIA) CONTROLS 16. MAGLUMI ANTI DSDNA (CLIA) CONTROLS 17. MAGLUMI ANA SCREEN (CLIA) CONTROLS 18. MAGLUMI ENA SCREEN (CLIA) CONTROLS 19. MAGLUMI ANTI SCL 70 IGG (CLIA) CONTROLS 20. MAGLUMI ANTI CENTROMERES IGG (CLIA) CONTROLS 21. MAGLUMI ANTI HISTONES IGG (CLIA) CONTROLS 22. MAGLUMI RIB P IGG (CLIA) CONTROLS 23. MAGLUMI SM IGG (CLIA) CONTROLS 24. MAGLUMI SS B IGG (CLIA) CONTROLS 25. MAGLUMI JO 1 IGG (CLIA) CONTROLS 26. MAGLUMI SM / RNP IGG (CLIA) CONTROLS 27. MAGLUMI SS A / RO IGG (CLIA) CONTROLS 28. MAGLUMI AMA M2 IGG (CLIA) CONTROLS

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IVD Registration Group A and BAug 11, 2023

1. MAGLUMI FSH (CLIA) 2. MAGLUMI LH (CLIA) 3. MAGLUMI TOTAL ßHCG (CLIA) 4. MAGLUMI PROLACTIN (CLIA) 5. MAGLUMI TESTOSTERONE (CLIA) 6. MAGLUMI FREE-TESTOSTERONE (CLIA) 7. MAGLUMI DHEA-S (CLIA) 8. MAGLUMI PROGESTERONE (CLIA) 9. MAGLUMI UNCONJUGATED ESTRIOL (CLIA) 10. MAGLUMI 17a-OH-PROGESTERONE (CLIA) 11. MAGLUMI AMH (CLIA) 12. MAGLUMI SHBG (CLIA) 13. MAGLUMI ANDROSTENEDIONE (CLIA) 14. MAGLUMI FSH (CLIA) CONTROLS 15. MAGLUMI LH (CLIA) CONTROLS 16. MAGLUMI TOTAL ßHCG (CLIA) CONTROLS 17. MAGLUMI PROLACTIN (CLIA) CONTROLS 18. MAGLUMI TESTOSTERONE (CLIA) CONTROLS 19. MAGLUMI FREE-TESTOSTERONE (CLIA) CONTROLS 20. MAGLUMI DHEA-S (CLIA) CONTROLS 21. MAGLUMI PROGESTERONE (CLIA) CONTROLS 22. MAGLUMI UNCONJUGATED ESTRIOL (CLIA) CONTROLS 23. MAGLUMI 17a-OH-PROGESTERONE (CLIA) CONTROLS 24. MAGLUMI AMH (CLIA) CONTROLS 25. MAGLUMI SHBG (CLIA) CONTROLS 26. MAGLUMI ANDROSTENEDIONE (CLIA) CONTROLS

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IVD Registration Group A and BAug 11, 2023

1. MAGLUMI EBV EA IGG (CLIA) 2. MAGLUMI EBV EA IGA (CLIA) 3. MAGLUMI EBV VCA IGG (CLIA) 4. MAGLUMI EBV VCA IGM (CLIA) 5. MAGLUMI EBV VCA IGA (CLIA) 6. MAGLUMI EBV AT IGG (CLIA) 7. MAGLUMI EBV AT IGA (CLIA) 8. MAGLUMI EBV EA IGG (CLIA) CONTROLS 9. MAGLUMI EBV EA IGA (CLIA) CONTROLS 10. MAGLUMI EBV VCA IGG (CLIA) CONTROLS 11. MAGLUMI EBV VCA IGM (CLIA) CONTROLS 12. MAGLUMI EBV VCA IGA (CLIA) CONTROLS 13. MAGLUMI EBV AT IGG (CLIA) CONTROLS 14. MAGLUMI EBV AT IGA (CLIA) CONTROLS

1. MAGLUMI EBV EA IGG (CLIA) 2. MAGLUMI EBV EA IGA (CLIA) 3. MAGLUMI EBV VCA IGG (CLIA) 4. MAGLUMI EBV VCA IGM (CLIA) 5. MAGLUMI EBV VCA IGA (CLIA) 6. MAGLUMI EBV NA IGG (CLIA) 7. MAGLUMI EBV NA IGA (CLIA) 8. MAGLUMI EBV EA IGG (CLIA) CONTROLS 9. MAGLUMI EBV EA IGA (CLIA) CONTROLS 10. MAGLUMI EBV VCA IGG (CLIA) CONTROLS 11. MAGLUMI EBV VCA IGM (CLIA) CONTROLS 12. MAGLUMI EBV VCA IGA (CLIA) CONTROLS 13. MAGLUMI EBV NA IGG (CLIA) CONTROLS 14. MAGLUMI EBV NA IGA (CLIA) CONTROLS

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IVD Registration Group A and BJul 28, 2023

1.-MAGLUMI TSH (CLIA) 2.-MAGLUMI TOTAL T4 (CLIA) 3.-MAGLUMI TOTAL T3 (CLIA) 4.-MAGLUMI FREE T4 (CLIA) 5.-MAGLUMI FREE T3 (CLIA) 6.-MAGLUMI THYROGLOBULIN (CLIA) 7.-MAGLUMI ANTI TG (CLIA) 8.-MAGLUMI ANTI TPO (CLIA) 9.-MAGLUMI TRAB (CLIA) 10.-MAGLUMI ANTI TM (CLIA) 11.-MAGLUMI REV T3 (CLIA) 12.-MAGLUMI T UPTAKE (CLIA) 13.-MAGLUMI TSH (CLIA) CONTROLS 14.-MAGLUMI TOTAL T4 (CLIA) CONTROLS 15.-MAGLUMI TOTAL T3 (CLIA) CONTROLS 16.-MAGLUMI FREE T4 (CLIA) CONTROLS 17.-MAGLUMI FREE T3 (CLIA) CONTROLS 18.-MAGLUMI THYROGLOBULIN (CLIA) CONTROLS 19.-MAGLUMI ANTI TG (CLIA) CONTROLS 20.-MAGLUMI ANTI TPO (CLIA) CONTROLS 21.-MAGLUMI TRAB (CLIA) CONTROLS 22.-MAGLUMI ANTI TM (CLIA) CONTROLS 23.-MAGLUMI REV T3 (CLIA) CONTROLS 24.-MAGLUMI T UPTAKE (CLIA) CONTROLS

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IVD Registration Group A and BJul 12, 2023