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BIODIAGNOSTICO S.A. - Authorized Company Profile

Explore comprehensive authorized company profile for BIODIAGNOSTICO S.A. through Pure Global AI's free Argentina medical device database. This company manufactures 229 medical devices registered with ANMAT across 4 registration types. Their registration history spans from Apr 11, 2018 to Jul 31, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Registration Group A and B: 148, Registration of products for IVD diagnostics - Group C and D: 18, IVD Modification Group A and B: 44, and more), 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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229 Devices
4 Registration Types
BIODIAGNOSTICO S.A.
Authorized Company
229
Total Devices
4
Registration Types
2018
Earliest
2024
Latest
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Recent Registrations
Latest 20 ANMAT device registrations

1)IgA Kit 2)IgG Kit 3)IgM Kit 4)C3 Kit 5) C4 Kit 6)Urine IgG Kit

1201-444

IVD Registration Group A and B
Jul 31, 2024

1. AMG Kit 2. A1M Kit 3. BMG Kit 4. RBP Kit 5. Cys C Kit 6. Urine TRF Kit 7. TRF Kit 8. ALB Kit 9. mALB Kit 10. PAB Kit

1201-447

IVD Registration Group A and B
Jul 30, 2024

1 446450 IMMAGE Immunochemistry Systems C3 Complement C3 Reagent 2 446490 IMMAGE Immunochemistry Systems C4 Complement C4 Reagent 3 447720 IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent 4 447070 IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent 5 446410 IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent 6 447730 IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent 7 446480 IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent 8 447630 IMMAGE Immunochemistry Systems TRF Transferrin Reagent 9 447700 IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent 10 447690 IMMAGE Immunochemistry Systems MA Microalbumin Reagent 11 447280 IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent 12 474630 IMMAGE Immunochemistry Systems CRPH High Sensitivity C-Reactive Protein Reagent 13 447740 IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent 14 474620 IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent 15 447620 IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent 16 447450 IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent 17 447760 IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent 18 447160 IMMAGE Immunochemistry Systems FER Ferritin Reagent 19 447440 IMMAGE Immunochemistry Systems PAB Prealbumin Reagent

1201-436

IVD Registration Group A and B
Jul 30, 2024

1) B1018-280 MicroScan autoSCAN-4 2) B1018-283 MicroScan WalkAway-40 plus 3) B1018-284 MicroScan WalkAway-96 plus 4) B1018-440 DxM 1040 MicroScan WalkAway Instrument 5) B1018-496 DxM 1096 MicroScan WalkAway Instrument 6) B1018-14 MicroScan RENOK Rehydrating/Inoculating System 7) B1013-4 MicroScan RENOK Disponsable D-Inoculator Sets

1201-441

IVD Registration Group A and B
Jul 30, 2024

1) UniCel DxI 600 Access Immunoassay System 2) UniCel DxI 600 Access Immunoassay System w/Dual Gantry 3) UniCel DxI 600 Access Immunoassay System w/Spot B Gantry 4) UniCel DxI 800 Access Immunoassay System 5) UniCel DxI 800 Access Immunoassay System w/Dual Gantry 6) UniCel DxI 800 Access Immunoassay System with w/Spot B Gantry 7) Access 2 Immunoassay System 8) Dxl 9000 Access Immunoassay Analyzer

1201-434

IVD Registration Group A and B
Jul 17, 2024

1. MicroScan PROMPT Inoculation System-D 2. MicroScan Inoculum Water 3. MicroScan Inoculum Water with Pluronic 4. Microscan Inoculum Saline with Pluronic 5. Microscan Inoculum Saline 3 ml 6. MicroScan Kovacยดs Reagent 7. MicroScan Alpha Naphthol 8. MicroScan 40% Potassium Hydroxide 9. MicroScan 0.8% Sulfanilic Acid 10. MicroScan 0.5% N, N-Dimethylalphanaphthylamine 11. MicroScan 10% Ferric Chloride 12. MicroScan Peptidase 13. MicroScan 0.05N Sodium Hydroxide 14. MicroScan Xylene 15. MicroScan Ehrlichยดs Reagent 16. MicroScan HNID Indole Reagent 17. MicroScan Rapid Indole Reagent-F

1201-439

IVD Registration Group A and B
Jul 17, 2024

1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3

1201-437

IVD Registration Group A and B
Jul 17, 2024

1 OSR61154 Ammonia 2 OSR6114 Cholinesterase 3 OSR6132 Total Protein 4 OSR6232 Total Protein 5 OSR6632 Total Protein 6 OSR62166 LIH

1201-429

IVD Registration Group A and B
Jul 15, 2024

1) DxH 500 Hematology Instrument 2) DxH 520 Hematology Instrument 3) DxH 560 Hematology Instrument 4) UniCel DxH 900 COULTER Cellular Analysis System 5) UniCel DxH 900 COULTER Cellular Analysis System with ESId Application 6) UniCel DxH Slidemaker Stainer II COULTER Cellular Analysis System 7) UniCel DxH 690 T Coulter Cellular Analysis System 8) Unicel DxH 800 COULTER Cellular Analysis System

1201-440

IVD Registration Group A and B
Jul 12, 2024

1. DxH 500 Series Diluent 2. DxH 500 Series Cleaner 3. DxH 500 Series Lyse 4. DxH 500 Series Controls 5. DxH 500 Series Calibrator 6. COULTER TruColor Wright Stain 7. COULTER TruColor Wright-Giemsa Stain 8. COULTER TruColor Wright Stain Buffer 9. COULTER TruColor Wright-Giemsa Stain Buffer 10. COULTER TruColor May-Grรผnwald Stain 11. COULTER TruColor Giemsa Stain 12. COULTER Retic-C Cell Control 9 x 3.3 mL

1201-438

IVD Registration Group A and B
Jul 12, 2024

QUANTA Lite sp100 ELISA

1201-71

IVD Modification Group A and B
Jul 10, 2024

1) TOXOPLASMA g. ELITe MGB Kit 2) TOXOPLASMA g.RE - ELITe Positive Control

1201-296

Agile modification of product registration for IVD diagnostics - Group C and D
Jul 05, 2024

Liquichek Therapeutic Drug Monitoring Control (TDM)

1201-78

Agile modification of product registration for IVD diagnostics - Group C and D
Jul 05, 2024

QUANTA Flash Ribosomal P Reagents QUANTA Flash Ribosomal P Calibrators QUANTA Flash Ribosomal P Controls

1201-210

IVD Modification Group A and B
Jul 01, 2024

1. ODR3021 Serum Protein Multi-Calibrator 1 2. ODR3023 Serum Protein Multi-Calibrator 2 3. ODC0014 ITA CONTROL SERUM 1 4. ODC0015 ITA CONTROL SERUM 2 5. ODC0016 ITA CONTROL SERUM 3 6. B64606 URINE CALIBRATOR 7. 66300 System calibrator 8. ODC0003 Control Serum 1 9. ODC0004 Control Serum 2 10. DR0070-1 Lyophilized Chemistry Calibrator Level 1 11. DR0070-2 Lyophilized Chemistry Calibrator Level 2 12. DR0090 URINE CHEMISTRY CALIBRATOR 13. DR0091 URINE CREATININE CALIBRATOR

1201-418

IVD Registration Group A and B
Jun 06, 2024

MYTHIC 70

1201-433

IVD Registration Group A and B
Jun 06, 2024

CHORUS Calprotectin K

1201-422

IVD Registration Group A and B
Jun 06, 2024

1 7546979 COULTER Retic-C Cell Control 6 x 2 mL 2 624671 COULTER Retic-C Cell Control 9 x 3.3 mL 3 624506 COULTER 5C Cell Control 4 7547001 COULTER 5C Cell Control 5 7547010 COULTER 5C Cell Control 6 7547011 COULTER 5C Cell Control 7 7547116 COULTER 5C Cell Control 8 7547117 COULTER 5C Cell Control 9 7547124 COULTER 5C Cell Control 10 7547199 COULTER 5C Cell Control 11 628024 COULTER Latron CP-X 12 628027 COULTER 6C Cell Control 13 A59925 COULTER 6C Cell Control 14 628028 COULTER Retic-X Cell Control 15 628029 COULTER LIN-X Linearity Control 16 628030 COULTER Body Fluid Control 17 C07297 Coulter 6C Plus Cell Control 18 179310 Coulter S-CAL Calibrator 1 x 4,2 mL 19 628026 Coulter S-CAL Calibrator 1 x 3,3 mL

1201-432

IVD Registration Group A and B
Jun 06, 2024

Real-Time PCR Assay for the Detection of Spinal Muscular Atrophy (SMA) Mutation from Dried Blood Spots of Neonates

Ensayo por PCR en Tiempo Real para la detecciรณn de la mutaciรณn de la atrofia muscular espinal (AME) a partir de manchas de sangre seca de neonatos

1201-420

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

1) B00389 HbA1c 2) 472137 Synchron and AU Systems Hemolyzing reagent 3) B93009 HbA1c Advanced

1201-431

IVD Registration Group A and B
May 16, 2024
Registration Type Distribution
Devices by registration type
IVD Registration Group A and B
148
64.6% of total
IVD Modification Group A and B
44
19.2% of total
Agile modification of product registration for IVD diagnostics - Group C and D
19
8.3% of total
Registration of products for IVD diagnostics - Group C and D
18
7.9% of total