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BERNARDO LEW E HIJOS SRL. - Authorized Company Profile

Explore comprehensive authorized company profile for BERNARDO LEW E HIJOS SRL. through Pure Global AI's free Argentina medical device database. This company manufactures 90 medical devices registered with ANMAT across 3 registration types. Their registration history spans from May 28, 2018 to Jul 19, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Registration Group A and B: 71, IVD Modification Group A and B: 12, Registration of products for IVD diagnostics - Group C and D: 7), and complete regulatory information from the official Argentina ANMAT (National Administration of Drugs, Foods and Medical Technology) medical device database with bilingual Spanish/English support. Pure Global AI offers free access to Argentina's complete medical device registry.

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90 Devices
3 Registration Types
BERNARDO LEW E HIJOS SRL.
Authorized Company
90
Total Devices
3
Registration Types
2018
Earliest
2024
Latest
Pure Global
DJ Fang

DJ Fang

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Recent Registrations
Latest 20 ANMAT device registrations

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)

1716-261

Registration of products for IVD diagnostics - Group C and D
Jul 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

1716-199

IVD Modification Group A and B
Jun 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

1716-263

Registration of products for IVD diagnostics - Group C and D
Jun 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

1716-288

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

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

1716-290

IVD Registration Group A and B
Apr 11, 2024

Finecare One Step c Tn T Rapid Quantitative Test

1716-271

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

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

1716-287

IVD Registration Group A and B
Feb 28, 2024

Microscope Slides

Microscope Slides (Portaobjetos para microscopios)

1716-289

IVD Registration Group A and B
Feb 09, 2024

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

1716-225

IVD Modification Group A and B
Feb 05, 2024

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

1716-246

IVD Registration Group A and B
Jan 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

1716-260

Registration of products for IVD diagnostics - Group C and D
Dec 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

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

1716-282

IVD Registration Group A and B
Oct 24, 2023

MAGLUMI HIV Ab/Ag Combi (CLIA)

MAGLUMI HIV Ab/Ag Combi (CLIA)

1716-254

Registration of products for IVD diagnostics - Group C and D
Oct 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

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

1716-281

IVD Registration Group A and B
Sep 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

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

1716-285

IVD Registration Group A and B
Sep 13, 2023

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

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

1716-268

IVD Registration Group A and B
Sep 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

1716-280

IVD Registration Group A and B
Aug 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

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

1716-278

IVD Registration Group A and B
Aug 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

1716-279

IVD Registration Group A and B
Jul 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

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

1716-277

IVD Registration Group A and B
Jul 12, 2023
Registration Type Distribution
Devices by registration type
IVD Registration Group A and B
71
78.9% of total
IVD Modification Group A and B
12
13.3% of total
Registration of products for IVD diagnostics - Group C and D
7
7.8% of total