Authorized company profileGEMATEC S.R.L.
179 devices registered with ANMAT · 4 registration types · May 08, 2018 – Aug 14, 2024
179
Total Devices
4
Registration Types
2018
Earliest
2024
Latest
Recent registrations
Latest 20 ANMAT device registrations
1) Prolactin MAGLUMI (CLIA).
2) MAGLUMI Progesterone (CLIA).
3) MAGLUMI Total ß HCG (CLIA).
4) MAGLUMI Free-Testosterone (CLIA).
5) MAGLUMI Prolactin (CLIA) Controls.
6) MAGLUMI Progesterone (CLIA) Controls.
7) MAGLUMI Total ß HCG (CLIA) Controls.
8) MAGLUMI Free-Testosterone (CLIA) Controls.
All the products, brand Snibe.
1) MAGLUMI Prolactin (CLIA).
2) MAGLUMI Progesterone (CLIA).
3) MAGLUMI Total ß HCG (CLIA).
4) MAGLUMI Free-Testosterone (CLIA).
5) MAGLUMI Prolactin (CLIA) Controls.
6) MAGLUMI Progesterone (CLIA) Controls.
7) MAGLUMI Total ß HCG (CLIA) Controls.
8) MAGLUMI Free-Testosterone (CLIA) Controls.
Todos los productos, marca Snibe.
1106-402
IVD Registration Group A and BAug 14, 2024
Reagent kit for hepatitis B surface antigen determination.
Kit de reactivos para determinación de antígeno de superficie de hepatitis B.
1106-385
Registration of products for IVD diagnostics - Group C and DJul 10, 2024
Reagent kit for determination of Chagas disease.
Kit de reactivos para determinación de Chagas.
1106-398
Registration of products for IVD diagnostics - Group C and DJul 01, 2024
Reagents for the determination of Syphilis.
Reactivos para determinación de Sífilis.
1106-399
Registration of products for IVD diagnostics - Group C and DJul 01, 2024
1) Auto Sample Processing System, CAL 6000.
2) Auto Sample Processing System, CAL 8000.
3) Concentrated Reagent Delivery System, CR-30[H].
Todos los productos, marca Mindray.
1106-397
IVD Registration Group A and BJun 06, 2024
1) MAGLUMI FSH (CLIA).
2) MAGLUMI LH (CLIA).
3) MAGLUMI Estradiol (CLIA).
4) Testosterone MAGLUMI (CLIA).
5) MAGLUMI DHEA-S (CLIA).
6) MAGLUMI AMH (CLIA).
7) MAGLUMI SHBG (CLIA).
8) MAGLUMI Androstenedione (CLIA).
9) MAGLUMI FSH (CLIA) Controls.
10) MAGLUMI LH (CLIA) Controls.
11) MAGLUMI Estradiol (CLIA) Controls.
12) MAGLUMI Testosterone (CLIA) Controls.
13) MAGLUMI DHEA-S (CLIA) Controls.
14) MAGLUMI AMH (CLIA) Controls.
15) MAGLUMI SHBG (CLIA) Controls.
16) MAGLUMI Androstenedione (CLIA) Controls.
All the products, brand Snibe.
1) MAGLUMI FSH (CLIA).
2) MAGLUMI LH (CLIA).
3) MAGLUMI Estradiol (CLIA).
4) MAGLUMI Testosterone (CLIA).
5) MAGLUMI DHEA-S (CLIA).
6) MAGLUMI AMH (CLIA).
7) MAGLUMI SHBG (CLIA).
8) MAGLUMI Androstenedione (CLIA).
9) MAGLUMI FSH (CLIA) Controls.
10) MAGLUMI LH (CLIA) Controls.
11) MAGLUMI Estradiol (CLIA) Controls.
12) MAGLUMI Testosterone (CLIA) Controls.
13) MAGLUMI DHEA-S (CLIA) Controls.
14) MAGLUMI AMH (CLIA) Controls.
15) MAGLUMI SHBG (CLIA) Controls.
16) MAGLUMI Androstenedione (CLIA) Controls.
Todos los productos, marca Snibe.
1106-401
IVD Registration Group A and BJun 06, 2024
1) Anti-ZnT8 MAGLUMI (CLIA).
2) MAGLUMI IAA (CLIA).
3) Proinsulin GLUMAS (CLIA).
4) MAGLUMI Insulin (CLIA).
5) C-Peptide (CLIA) MAGLUMAS
6) MAGLUMI ICA (CLIA).
7) Anti-IA2 MAGLUMI (CLIA).
8) Anti-GAD MAGLUMI (CLIA).
9) MAGLUMI Anti-ZnT8 (CLIA) Controls.
10) MAGLUMI IAA (CLIA) Controls.
11) MAGLUMI Proinsulin (CLIA) Controls.
12) MAGLUMI Insulin (CLIA) Controls.
13) MAGLUMI C-Peptide (CLIA) Controls.
14) MAGLUMI ICA (CLIA) Controls.
15) MAGLUMI Anti-IA2 (CLIA) Controls.
16) MAGLUMI Anti-GAD (CLIA) Controls.
All the products, brand Snibe.
1) MAGLUMI Anti-ZnT8 (CLIA).
2) MAGLUMI IAA (CLIA).
3) MAGLUMI Proinsulin (CLIA).
4) MAGLUMI Insulin (CLIA).
5) MAGLUMI C-Peptide (CLIA).
6) MAGLUMI ICA (CLIA).
7) MAGLUMI Anti-IA2 (CLIA).
8) MAGLUMI Anti-GAD (CLIA).
9) MAGLUMI Anti-ZnT8 (CLIA) Controls.
10) MAGLUMI IAA (CLIA) Controls.
11) MAGLUMI Proinsulin (CLIA) Controls.
12) MAGLUMI Insulin (CLIA) Controls.
13) MAGLUMI C-Peptide (CLIA) Controls.
14) MAGLUMI ICA (CLIA) Controls.
15) MAGLUMI Anti-IA2 (CLIA) Controls.
16) MAGLUMI Anti-GAD (CLIA) Controls.
Todos los productos, marca Snibe.
1106-403
IVD Registration Group A and BJun 06, 2024
1) MAGLUMI EPO (CLIA).
2) MAGLUMI EPO (CLIA) Controls.
3) MAGLUMI Vitamin B12 (CLIA).
4) MAGLUMI Ferritin (CLIA).
5) MAGLUMI FA (CLIA).
6) MAGLUMI Sample Release Agent.
7) MAGLUMI Vitamin B12 (CLIA) Controls.
8) MAGLUMI Ferritin (CLIA) Controls.
9) MAGLUMI FA (CLIA) Controls.
All the products, brand Snibe.
1) MAGLUMI EPO (CLIA).
2) MAGLUMI EPO (CLIA) Controls.
3) MAGLUMI Vitamin B12 (CLIA).
4) MAGLUMI Ferritin (CLIA).
5) MAGLUMI FA (CLIA).
6) MAGLUMI Sample Release Agent.
7) MAGLUMI Vitamin B12 (CLIA) Controls.
8) MAGLUMI Ferritin (CLIA) Controls.
9) MAGLUMI FA (CLIA) Controls.
Todos los productos, marca Snibe.
1106-360
IVD Modification Group A and BMay 27, 2024
1) MAGLUMI Dengue virus NS1 Antigen (CLIA).
2) MAGLUMI Anti-Dengue Virus IgG (CLIA).
3) MAGLUMI Anti-Dengue Virus IgM (CLIA).
4) MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls.
5) MAGLUMI Anti-Dengue Virus IgG (CLIA) Controls.
6) MAGLUMI Anti-Dengue Virus IgM (CLIA) Controls.
Todos los productos, marca Snibe.
1106-400
IVD Registration Group A and BMay 27, 2024
Reagent kit for simultaneous determination of HIV antigen and antibodies.
Kit de reactivos para determinación simultánea de antígeno y anticuerpos de VIH.
1106-383
Agile modification of product registration for IVD diagnostics - Group C and DMay 27, 2024
1) Anti-cardiolipin IgG (CLIA) GLUMAS
2) Anti-Cardiolipin IgG (CLIA) Controls Glumas.
3) Anti-Cardiolipin IgM (CLIA) MAGLUMA.
4) MAGLUMI Anti-Cardiolipin IgM (CLIA) Controls.
5) MAGLUMI Anti-ß2-Glycoprotein 1 IgG (CLIA).
6) MAGLUMI Anti-ß2-Glycoprotein 1 IgG (CLIA) Controls.
7) MAGLUMI Anti-ß2-Glycoprotein 1 IgM (CLIA).
8) MAGLUMI Anti-ß2-Glycoprotein 1 IgM (CLIA) Controls.
9) MAGLUMI Anti-tissue Transglutaminase IgA (CLIA).
10) MAGLUMI Anti-tissue Transglutaminase IgA (CLIA) Controls.
11) MAGLUMI Anti-tissue Transglutaminase IgG (CLIA).
12) MAGLUMI Anti-tissue Transglutaminase IgG (CLIA) Controls.
13) Anti-DGP IgA (CLIA) MAGLUMI.
14) MAGLUMI Anti-DGP IgA (CLIA) Controls.
15) Anti-DGP IgG (CLIA) MAGLUMAS
16) MAGLUMI Anti-DGP IgG (CLIA) Controls.
17) Anti-CCP (CLIA) GLUMI.
18) Anti-dsDNA IgG (CLIA) GLUMAS
19) MAGLUMI ANA Screen (CLIA).
20) MAGLUMI ENA Screen (CLIA).
21) MAGLUMI Anti-CCP (CLIA) Controls.
22) MAGLUMI Anti-dsDNA IgG (CLIA) Controls.
23) MAGLUMI ANA Screen (CLIA) Controls.
24) MAGLUMI ENA Screen (CLIA) Controls.
All the products, brand Snibe.
1) MAGLUMI Anti-Cardiolipin IgG (CLIA).
2) MAGLUMI Anti-Cardiolipin IgG (CLIA) Controls.
3) MAGLUMI Anti-Cardiolipin IgM (CLIA).
4) MAGLUMI Anti-Cardiolipin IgM (CLIA) Controls.
5) MAGLUMI Anti-ß2-Glycoprotein 1 IgG (CLIA).
6) MAGLUMI Anti-ß2-Glycoprotein 1 IgG (CLIA) Controls.
7) MAGLUMI Anti-ß2-Glycoprotein 1 IgM (CLIA).
8) MAGLUMI Anti-ß2-Glycoprotein 1 IgM (CLIA) Controls.
9) MAGLUMI Anti-tissue Transglutaminase IgA (CLIA).
10) MAGLUMI Anti-tissue Transglutaminase IgA (CLIA) Controls.
11) MAGLUMI Anti-tissue Transglutaminase IgG (CLIA).
12) MAGLUMI Anti-tissue Transglutaminase IgG (CLIA) Controls.
13) MAGLUMI Anti-DGP IgA (CLIA).
14) MAGLUMI Anti-DGP IgA (CLIA) Controls.
15) MAGLUMI Anti-DGP IgG (CLIA).
16) MAGLUMI Anti-DGP IgG (CLIA) Controls.
17) MAGLUMI Anti-CCP (CLIA).
18) MAGLUMI Anti-dsDNA IgG (CLIA).
19) MAGLUMI ANA Screen (CLIA).
20) MAGLUMI ENA Screen (CLIA).
21) MAGLUMI Anti-CCP (CLIA) Controls.
22) MAGLUMI Anti-dsDNA IgG (CLIA) Controls.
23) MAGLUMI ANA Screen (CLIA) Controls.
24) MAGLUMI ENA Screen (CLIA) Controls.
Todos los productos, marca Snibe.
1106-358
IVD Modification Group A and BMay 27, 2024
1) Anti-Scl-70 IgG (CLIA) GLUMAS
2) Anti-Centromeres IgG (CLIA) MAGLUMAS
3) Anti-Histones IgG (CLIA) MAGLUMAS
4) Anti-Rib-P IgG (CLIA) MAGLUMAS
5) Anti-Sm IgG (CLIA) GLUMAS
6) Anti-SS-B IgG (CLIA) GLUMAs
7) Anti-Jo-1 IgG MAGLUMI (CLIA).
8) Anti-Sm/RNP IgG (CLIA) GLUMAS
9) Anti-SS-A/Ro IgG (CLIA) MAGLUMI.
10) AMA-M2 IgG GLUMAS (CLIA).
11) Anti-MPO IgG (CLIA) GLUMAS
12) MAGLUMI Anti-Scl-70 IgG (CLIA) Controls.
13) Anti-Centromeres IgG (CLIA) Controls MAGLUMAS.
14) MAGLUMI Anti-Histones IgG (CLIA) Controls.
15) MAGLUMI Anti-Rib-P IgG (CLIA) Controls.
16) MAGLUMI Anti-Sm IgG (CLIA) Controls.
17) Anti-SS-B IgG (CLIA) Controls.
18) MAGLUMI Anti-Jo-1 IgG (CLIA) Controls.
19) MAGLUMI Anti-Sm/RNP IgG (CLIA) Controls.
20) MAGLUMI Anti-SS-A/Ro IgG (CLIA) Controls.
21) MAGLUMI AMA-M2 IgG (CLIA) Controls.
22) Anti-MPO IgG (CLIA) Controls.
All the products, brand Snibe.
1) MAGLUMI Anti-Scl-70 IgG (CLIA).
2) MAGLUMI Anti-Centromeres IgG (CLIA).
3) MAGLUMI Anti-Histones IgG (CLIA).
4) MAGLUMI Anti-Rib-P IgG (CLIA).
5) MAGLUMI Anti-Sm IgG (CLIA).
6) MAGLUMI Anti-SS-B IgG (CLIA).
7) MAGLUMI Anti-Jo-1 IgG (CLIA).
8) MAGLUMI Anti-Sm/RNP IgG (CLIA).
9) MAGLUMI Anti-SS-A/Ro IgG (CLIA).
10) MAGLUMI AMA-M2 IgG (CLIA).
11) MAGLUMI Anti-MPO IgG (CLIA).
12) MAGLUMI Anti-Scl-70 IgG (CLIA) Controls.
13) MAGLUMI Anti-Centromeres IgG (CLIA) Controls.
14) MAGLUMI Anti-Histones IgG (CLIA) Controls.
15) MAGLUMI Anti-Rib-P IgG (CLIA) Controls.
16) MAGLUMI Anti-Sm IgG (CLIA) Controls.
17) MAGLUMI Anti-SS-B IgG (CLIA) Controls.
18) MAGLUMI Anti-Jo-1 IgG (CLIA) Controls.
19) MAGLUMI Anti-Sm/RNP IgG (CLIA) Controls.
20) MAGLUMI Anti-SS-A/Ro IgG (CLIA) Controls.
21) MAGLUMI AMA-M2 IgG (CLIA) Controls.
22) MAGLUMI Anti-MPO IgG (CLIA) Controls.
Todos los productos, marca Snibe.
1106-404
IVD Registration Group A and BMay 27, 2024
Reagents for cytomegalovirus detection.
Reactivos para detección de citomegalovirus.
1106-393
Registration of products for IVD diagnostics - Group C and DApr 29, 2024
Automatic microbial identification system and antimicrobial susceptibility test.
Sistema automático de identificación microbiana y test de susceptibilidad de antimicrobianos.
1106-362
Agile modification of product registration for IVD diagnostics - Group C and DApr 25, 2024
1) BC-6000.
2) BC-6200.
3) BC-6800Plus.
4) DS DILUENT.
5) M-6DR DILUENT.
6) M-6LH LYSE.
7) M-6LD LYSE.
8) M-6LN LYSE.
9) M-6FR DYE.
10) M-6FN DYE.
11) M-6FD DYE.
Todos los productos, marca Mindray.
1106-297
IVD Modification Group A and BApr 24, 2024
1) TURN 600.
2) TURN 800.
3) TURN 1000.
4) TURN 1000 Plus.
5) TURN 2000.
6) MAGLUMI 2000 Plus.
7) TURN 4000.
8) TURN 4000 Plus.
9) TURN X8.
10) TURN X3.
11) PLEASE TIP.
12) MAGLUMI Reaction Cup.
13) MAGLUMI waste bag.
14) MAGLUMI Starter 1+2.
15) TURN X6.
16) MAGLUMI Wash Concentrate.
17) System Tubing Cleaning Solution.
18) TURN LIGHT Check.
19) MAGLUMI Reaction Module.
1) MAGLUMI 600.
2) MAGLUMI 800.
3) MAGLUMI 1000.
4) MAGLUMI 1000 Plus.
5) MAGLUMI 2000.
6) MAGLUMI 2000 Plus.
7) MAGLUMI 4000.
8) MAGLUMI 4000 Plus.
9) MAGLUMI X8.
10) MAGLUMI X3.
11) MAGLUMI Tip.
12) MAGLUMI Reaction Cup.
13) MAGLUMI Waste Bag.
14) MAGLUMI Starter 1+2.
15) MAGLUMI X6.
16) MAGLUMI Wash Concentrate.
17) System Tubing Cleaning Solution.
18) MAGLUMI Light Check.
19) MAGLUMI Reaction Module.
1106-347
IVD Modification Group A and BApr 24, 2024
MR Buffer Solution.
MR Serum Standard.
MR Urine Standard.
MR Urine Quality Control.
MR Detergent Solution.
MR Na/K Check Solution.
Reference Electrode.
Sodium Electrode.
Potassium Electrode.
Chloride Electrode.
Todos los productos, marca Mindray.
1106-241
IVD Modification Group A and BApr 24, 2024
[610189] Alethia, Automated Isothermal Amplification and Detection System.
Marca Meridian.
1106-392
IVD Registration Group A and BMar 25, 2024
Reagent kit for hepatitis C antibody determination.
Kit de reactivos para determinación de anticuerpo de hepatitis C.
1106-384
Registration of products for IVD diagnostics - Group C and DMar 22, 2024
Microspope Slides.
1106-395
IVD Registration Group A and BMar 20, 2024
Registration type distribution
Devices by registration type
IVD Registration Group A and B
133
74.3% of total
IVD Modification Group A and B
36
20.1% of total
Registration of products for IVD diagnostics - Group C and D
8
4.5% of total
Agile modification of product registration for IVD diagnostics - Group C and D
2
1.1% of total
About this profile
Explore comprehensive authorized company profile for GEMATEC S.R.L. through Pure Global AI's free Argentina medical device database. This company manufactures 179 medical devices registered with ANMAT across 4 registration types. Their registration history spans from May 08, 2018 to Aug 14, 2024.
This page provides detailed insights including recent registrations, registration type distribution (IVD Modification Group A and B: 36, Registration of products for IVD diagnostics - Group C and D: 8, IVD Registration Group A and B: 133, 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.
Free Authorized Company ProfilePowered by Pure Global AI179 Devices4 Registration Types