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Analizi.com.ge2

Enzyme Immunoassay (EIA) Kits
□ Thyroid □ TORCH and Infectious Diseases
□ Fertility □ Steroids
□ Tumor Markers □ Other Analytes
□ Cardiac Markers

Tiroiduli funqcia / THYROID
Intended Use: For the in vitro quantitative determination of the thyroid stimulating hormone
(TSH) concentration in human serum.
Minimum Sensitivity: 0.2 µIU/ml
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of the thyroid stimulating hormone
(TSH) concentration in human serum.
Minimum Sensitivity: 0.05 µIU/ml
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of the Total Triiodothyronine (T3)
concentration in human serum.
Minimum Sensitivity: 0.2 ng/ml
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of Free Triiodothyronine (fT3)
concentration in human serum.
Minimum Sensitivity: 0.05 pg/ml
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of the Total Thyroxine (T4)
concentration in human serum.
Minimum Sensitivity: 0.4µg/dl
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of Free Thyroxine (fT4) concentration
Minimum Sensitivity: 0.05 ng/dl
FDA Cleared, CE Cleared
nayofiereba / FERTILITY
Intended Use: For the in vitro quantitative determination of Human Chorionic Gonadotropin
(hCG) concentration in human serum.
Minimum Sensitivity: 2.0 mIU/ml
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of follicle-stimulation hormone (FSH)
concentration in human serum.
Minimum Sensitivity: 2.5 mIU/ml
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of luteinizing hormone (LH)
concentration in human serum.
Minimum Sensitivity: 1.0 mIU/ml
FDA Cleared, CE Cleared
Prolactin
Intended Use: For the in vitro quantitative determination of prolactin concentration in human
serum.
Minimum Sensitivity: 2.0 ng/ml
FDA Cleared, CE Cleared
Visual hCG Pregnancy
Intended Use: For the in vitro qualitative determination of Human Chorionic Gonadotropin
(hCG) in human urine or serum.
Cut-off Point: 20 mIU/ml
CE Cleared
daavadebaTa markerebi / TUMOR MARKERS
AFP (standard range)
Intended Use: For the quantitative determination of the cancer antigen alpha-fetoprotein (AFP)
concentration in human serum.
Minimum Sensitivity: 2.0 ng/ml
Standard Curve Range: 0-300 ng/ml
CE Cleared
AFP (extended range)
Intended Use: For the quantitative determination of the cancer antigen alpha-fetoprotein (AFP)
concentration in human serum.
Minimum Sensitivity: 2.0 ng/ml
Standard Curve Range: 0-1000 ng/ml
CE Cleared
Intended Use: For the quantitative determination of carcinoembroyonic antigen (CEA)
concentration in human serum.
Minimum Sensitivity: 1.0 ng/ml
CE Cleared
Intended Use: For the quantitative determination of the cancer antigen CA125 concentration
in human serum.
Minimum Sensitivity: 5.0 U/ml
CE Cleared
Intended Use: For the quantitative determination of the cancer antigen CA15-3 concentration
in human serum.
Minimum Sensitivity: 5.0 U/ml
CE Cleared
Intended Use: For the quantitative determination of the cancer antigen CA19-9 concentration
in human serum.
Minimum Sensitivity: 5.0 U/ml
CE Cleared
Intended Use: For the quantitative determination of the cancer antigen PSA concentration
in human serum.
Minimum Sensitivity: 0.25 ng/ml
CE Cleared
Intended Use: For the quantitative determination of the cancer antigen f-PSA concentration
in human serum.
Minimum Sensitivity: 0.1 ng/ml
Free beta-hCG
Intended Use: For the quantitative determination of free beta subunit of human chorionic
gonadotropin (free beta-hCG) concentration in human serum.
Minimum Sensitivity: 0.25 ng/ml
Beta-2 Microglobulin
Intended Use: For the quantitative determination of beta-2 Microglobulin (B2MG) concentration
in human serum.
Minimum Sensitivity: 0.1 µg/ml
FDA Cleared, CE Cleared
gulis markerebi / CARDIAC MARKERS
Troponin I
Intended Use: For the in vitro quantitative determination of cardiac troponin I in human serum.
Minimum Sensitivity: 1.0 ng/ml
FDA Cleared, CE Cleared
Myoglobin
Intended Use: For the in vitro quantitative determination of myoglobin concentration in human
serum.
Minimum Sensitivity: 5.0 ng/ml
FDA Cleared, CE Cleared
C-Reactive Protein
Intended Use: For the in vitro quantitative determination of C-Reactive Protein (CRP)
concentration in human serum.
Minimum Sensitivity: 0.1 mg/L
FDA Cleared, CE Cleared
Intended Use: For the quantitative determination of CK-MB concentration in human serum.
Minimum Sensitivity: 2.5 ng/ml
Fatty Acid Binding Protein (FABP)
Intended Use: For the quantitative determination of FABP concentration in human serum,
heparin-plasma, EDTA plasma, or citrate-plasma.
Minimum Sensitivity: 0.25 ng/ml
Myeloperoxidase (MPO)
Intended Use: For the quantitative determination of Myeloperoxidase (MPO) in human serum
or heparin-plasma.
Minimum Sensitivity: 0.25 ng/ml
anTebiTi da infeqciuri daavadebebi / TORCH AND INFECTIOUS DISEASES
TORCH
Toxoplasma IgG
Intended Use: For the detection of IgG to Toxoplasma gondii infection in human serum.
Toxoplasma IgM
Intended Use: For the detection of IgM to Toxoplasma gondii infection in human serum.
Rubella IgG
Intended Use: For the detection of IgG rubella virus infection in human serum.
Rubella IgM
Intended Use: For the detection of IgM to the rubella virus infection in human serum.
Intended Use: For the detection of IgG to cytomegalovirus (CMV) infection in human serum.
Intended Use: For the detection of IgM to cytomegalovirus (CMV) infection in human serum.
HSV-1 IgG
Intended Use: For the detection of IgG to herpes simplex virus (HSV) type 1 infection in human
serum.
CE Cleared
HSV-1 IgM
Intended Use: For the detection of IgM to herpes simplex virus (HSV) type 1 infection in human
serum.
CE Cleared
HSV-2 IgG
Intended Use: For the detection of IgG to herpes simplex virus (HSV) type 2 infection in human
serum.
CE Cleared
HSV-2 IgM
Intended Use: For the detection of IgM to herpes simplex virus (HSV) type 2 infection in human
serum.
CE Cleared
INFECTIOUS DISEASES
H. pylori IgG (Qualitative)
Intended Use: For the detection of IgG to Helicobacter pylori infection in human serum.
CE Cleared
H. pylori IgG (Quantitative)
Intended Use: For the quantitative determination of IgG to Helicobacter pylori infection in
human serum.
CE Cleared
H. pylori IgM (Qualitative)
Intended Use: For the detection of IgM to Helicobacter pylori infection in human serum.
CE Cleared
steroidebi / STEROIDS
Estradiol
Intended Use: For the in vitro quantitative determination of estradiol (E2) concentration in
human serum.
Minimum Sensitivity: 10 pg/ml
FDA Cleared, CE Cleared
Progesterone
Intended Use: For the in vitro quantitative determination of progesterone concentration in
human serum.
Minimum Sensitivity: 0.05 ng/ml
FDA Cleared, CE Cleared
Testosterone
Intended Use: For the in vitro quantitative determination of testosterone concentration in
human serum.
Minimum Sensitivity: 0.05 ng/ml
FDA Cleared, CE Cleared
sxvadasxva / OTHER ANALYTES
Human Ferritin
Intended Use: For the in vitro quantitative determination of Human Ferritin concentration in
human serum.
Minimum Sensitivity: 5.0 ng/ml
FDA Cleared, CE Cleared
Intended Use: For the in vitro quantitative determination of the Human Growth Hormone (HGH)
concentration in human serum.
Minimum Sensitivity: 0.5 ng/ml
Intended Use: For the in vitro quantitative determination of Immunoglobulin E (IgE)
concentration in human serum.
Minimum Sensitivity: 5.0 IU/ml

Source: http://www.analizi.com.ge/files/Biocheck,%20inc..pdf

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