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Areta 5 Panel Drug Test Cup (50 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution
- 00855944007543 ()
- 30855944007544 ()
ACDOA-754-50
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 5 Panel Drug Test Cup (10 Test Kit) - THC,COC,OPI2000,BZO,AMP
EASY HEALTHCARE CORPORATION
ACDOA-754
In Commercial Distribution
- 00855944007536 ()
- 30855944007537 ()
ACDOA-754-10
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (100 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution
- 00855944007529 ()
- 30855944007520 ()
ACDOA-264-100
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (50 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution
- 00855944007512 ()
- 30855944007513 ()
ACDOA-264-50
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (25 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution
- 00855944007505 ()
- 30855944007506 ()
- 10855944007502 ()
ACDOA-264-25
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Areta 6 Panel Drug Test Cup (10 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
EASY HEALTHCARE CORPORATION
ACDOA-264
In Commercial Distribution
- 00855944007499 ()
- 30855944007490 ()
ACDOA-264-10
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
VARIAN MEDICAL SYSTEMS, INC.
17.0
In Commercial Distribution
- 00856100006189 ()
- Radiation therapy treatment record/verify system
No Description
VARIAN MEDICAL SYSTEMS, INC.
16.1
In Commercial Distribution
- 00856100006165 ()
- Radiation therapy treatment record/verify system
INTENDED USE
An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by
oxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupus
erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.
SUMMARY AND EXPLANATION OF THE ASSAY
The antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability
(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such as
SLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease
(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important.
PRINCIPLE OF THE TEST
This test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert.
CORGENIX MEDICAL CORPORATION
11854
Not in Commercial Distribution
- 00855360006236 ()
11854
- Oxidized low density lipoprotein-B2-glycoprotein I (OxLDL-B2GPI) complex antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE
For the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.
SUMMARY OF THE TEST
Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to product package insert.
CORGENIX MEDICAL CORPORATION
13372
In Commercial Distribution
- 00855360006199 ()
13372
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)