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The PG5701 Detection Reagent is used for amplification of the HLA-B*5701 allele.
PHARMIGENE, Inc.
PG-5701A-024
In Commercial Distribution
- 04719872780618 ()
- HLA class I & II antigen nucleic acid tissue typing IVD, primer
The PG5801 Detection Reagent is used for amplification of the HLA-B*5801 allele.
PHARMIGENE, Inc.
PG-5801A-024
In Commercial Distribution
- 04719872780441 ()
- HLA class I & II antigen nucleic acid tissue typing IVD, primer
The PG1502 Detection Reagent is used for amplification of the HLA-B*1502 allele.
PHARMIGENE, Inc.
PG-1502A-024
In Commercial Distribution
- 04719872780205 ()
- HLA class I & II antigen nucleic acid tissue typing IVD, primer
No Description
Biomet Orthopedics, LLC
110004132
In Commercial Distribution
- 00880304567061 ()
- I
110004132
- Instrument tray, reusable
SCREW I - CONNECTOR I
Zimmer GmbH
01.04558.309
In Commercial Distribution
- 00889024387294 ()
01.04558.309
- Orthopaedic implant-instrument extension adaptor, reusable
1. Antibody coated plate
12x8 wells coated with antibody against calprotectin. Plastic sealed bag containing a desiccant.
2. Enzyme conjugate antibody (IgG)
1 vial containing 15 ml Horse-radish peroxidase-labeled rabbit anti-human calprotectin IgG antibodies in a buffer solution with Proclin 300 as a preservative. Ready-to-use.
3. Substrate
1 vial containing 15 ml substrate reagent (TMB). Ready-to-use
4. Stop Solution
1 vial containing 15 ml H2SO4 (0.5M). Ready-to-use
5. Washing solution (20x)
1 vial containing 50 ml concentrated washing solution. To be diluted with distilled water.
6. Diluent solution (10x)
1 vial containing 20 ml concentrated diluent solution to be diluted with distilled water.
7. Extraction solution (2.5x)
2 vials containing 100 ml concentrated extraction solution to be diluted with distilled water. This concentrated solution is irritating to eyes and skin.
8. Calibrators
6 vials containing 1.5 ml Calprotectin solution at six known concentrations (0, 2.5, 12.5, 25, 50, 150 ng/ml). The value of each Calibrator is printed on the vial label. Ready-to-use.
9. Control 1
1 vial containing 1.5 ml of control 1. Ready-to-use. Do not dilute. The range of values is printed on the vial label.
10. Control 2
1 vial containing 1.5 ml of control 2. Ready-to-use. Do not dilute. The range of values is printed on the vial label.
INOVA DIAGNOSTICS, INC.
704860
In Commercial Distribution
- 08426950913337 ()
- Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)
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)
1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 00009800016
2. 1 Resuspension buffer (Cat. No. 00009800019)
3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):
4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018):
INSTRUMENTATION LABORATORY COMPANY
00009800015
In Commercial Distribution
- 08426951298778 ()
00009800015
- Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
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