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1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge
2. 1 QUANTA Flash B2GP1 IgM Calibrator 1
3. 1 QUANTA Flash B2GP1 IgM Calibrator 2
INOVA DIAGNOSTICS, INC.
701250
In Commercial Distribution
- 08426951289271 ()
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1 QUANTA Flash B2GP1 IgG Reagent Cartridge
1 QUANTA Flash B2GP1 IgG Calibrator 1
1 QUANTA Flash B2GP1 IgG Calibrator 2
INOVA DIAGNOSTICS, INC.
701245
In Commercial Distribution
- 08426951289264 ()
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge
2. 1 QUANTA Flash B2GP1 IgA Calibrator 1
3. 1 QUANTA Flash B2GP1 IgA Calibrator 2
INOVA DIAGNOSTICS, INC.
701240
In Commercial Distribution
- 08426951289257 ()
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge
2. 1 Resuspension buffer
3. 1 Transfer pipet
4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 1
5. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2
INOVA DIAGNOSTICS, INC.
701188
In Commercial Distribution
- 08426950601951 ()
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge
2. 1 QUANTA Flash ß2GP1 IgA Calibrator 1
3. 1 QUANTA Flash ß2GP1 IgA Calibrator 2
INOVA DIAGNOSTICS, INC.
701243
In Commercial Distribution
- 08426950596820 ()
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge
2. 1 QUANTA Flash β2GP1 IgM Calibrator 1
3. 1 QUANTA Flash β2GP1 IgM Calibrator 2
INOVA DIAGNOSTICS, INC.
701253
In Commercial Distribution
- 08426950594475 ()
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. QUANTA Flash β2GP1 IgG Reagent Cartridge
1. QUANTA Flash β2GP1 IgG Calibrator 1
1. QUANTA Flash β2GP1 IgG Calibrator 2
INOVA DIAGNOSTICS, INC.
701248
In Commercial Distribution
- 08426950594420 ()
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
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)
Tinted Liquid
JBC and Company
I
In Commercial Distribution
- D851I0 ()
I
- Dental appliance fabrication material, resin
No Description
BIOGENEX LABORATORIES
AM880-5M
In Commercial Distribution
- 00810119671875 ()
- Total Volume: 6 Milliliter
AM880-5M
- Multiple gastrointestinal disease marker IVD, reagent