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INTENDED USE
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.
SUMMARY AND EXPLANATION OF THE IGA TEST
Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 IgA aCL antibodies.
Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. The O.D. values of the controls and patient samples are multiplied by the conversion factor to obtain IgA aCL values, expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert.
CORGENIX MEDICAL CORPORATION
026-001
In Commercial Distribution
- 00855360006052 ()
026-001
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.
SUMMARY AND EXPLANATION OF THE TEST
Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG or IgM labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 aCL antibodies. Results are obtained by reading the O.D. of each test well with a spectrophotometer. Calibrator sera are provided, with the IgG and IgM aCL concentrations expressed in GPL or MPL units, respectively. The O.D. values of all the other samples are multiplied by the conversion factors to obtain IgG and IgM aCL antibody concentrations in standard units. Control and patient results are determined from the calibration curve. Refer to Product Product Insert.
CORGENIX MEDICAL CORPORATION
023-001
In Commercial Distribution
- 00855360006045 ()
023-001
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
ANTI-BETA 2 GLYCOPROTEIN I ANTIBODY SCREENING ELISA TEST KIT, 96 TESTS
THERA-TEST LABORATORIES, INC
402-401
In Commercial Distribution
- 00854473003286 ()
402-401
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
ANTI-CARDIOLIPIN ANTIBODY SCREENING ELISA TEST KIT, 192 TESTS
THERA-TEST LABORATORIES, INC
202-202
In Commercial Distribution
- 00854473003200 ()
202-202
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
ANTI-BETA 2 GLYCOPROTEIN I ANTIBODY ELISA TEST KIT IgM, IgG, IgA, 192 TESTS
THERA-TEST LABORATORIES, INC
401-404
In Commercial Distribution
- 00854473003040 ()
401-404
- Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn’s disease in combination with clinical and other laboratory findings.
FOR IN VITRO DIAGNOSTIC USE.
TECHLAB, INC.
T5016
In Commercial Distribution
- 00857031002325 ()
- Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA)
In Vitro Diagnostics testing kit R1:5X30mL
CLEARCHEM DIAGNOSTICS INC.
URA1500
In Commercial Distribution
- 00852169008263 ()
- Total Volume: 150 Milliliter
URA1500
- Uric acid IVD, reagent
Impression Material (VPS), Mixing Tips, Medium & Heavy Body, 50/Bag
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Mixing Tips - Medium & Heavy Body - 50pk
In Commercial Distribution
- 00850058951331 ()
AMTMBHB-MT
- Silicone dental impression material
Impression Material (VPS), Mixing Tips, Lite Body, 50/Bag
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Mixing Tips - Lite Body - 50pk
In Commercial Distribution
- 00850058951324 ()
AMTLB-MT
- Silicone dental impression material
Amtouch Impression Material (VPS) - Medium Body / Fast Set (2x Cartridges, 6x Tips)
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Medium Body - Fast Set
In Commercial Distribution
- 00850058951317 ()
AMTMBFS
- Silicone dental impression material
Amtouch Impression Material (VPS) - Medium Body / Regular Set (2x Cartridges, 6x Tips)
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
Medium Body - Regular Set
In Commercial Distribution
- 00850058951300 ()
AMTMBRS
- Silicone dental impression material
Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Cardiolipin G
In Commercial Distribution
- 00850487007517 ()
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
Cardiolipin G
In Commercial Distribution
- 00850487007227 ()
- Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Bendable disposable tips (assortment of 25 tips) for use with AMD LASERS' Picasso Line of Soft-Tissue Dental Lasers. Contains ten (10) 400um core diameter 5mm length tips, ten (10) 400um core diameter 10mm length tips, and five (5) 300um core diameter 10mm length tips. All tips are pre-bent to 60 degree angle.
AMD Lasers
TIP25
Not in Commercial Distribution
- 00851759007020 ()
- Angle: 60 degree
TIP25
- Dental diode laser system
ANESTHESIA CIRCUIT PEDS 120-LF
MEDLINE INDUSTRIES, INC.
DYNJAP9962
In Commercial Distribution
- 10889942748389 ()
- 40889942748380 ()
DYNJAP9962
- General surgical procedure kit, non-medicated, single-use
ANESTHESIA CIRC PEDS 72" UNI
MEDLINE INDUSTRIES, INC.
DYNJAPF6064
In Commercial Distribution
- 10889942748372 ()
- 40889942748373 ()
DYNJAPF6064
- General surgical procedure kit, non-medicated, single-use
No Description
Biomedica ADI Inc.
820
In Commercial Distribution
- 00850201006031 ()
820
- Coagulation factor IIa (thrombin) IVD, kit, chromogenic
25 tests kit; Strep A Swab Test Strip ( Individually wrapped)
EASY HEALTHCARE CORPORATION
ARST-100S
In Commercial Distribution
- 10850253007748 ()
- 00850253007741 ()
- 30850253007742 ()
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
25 tests kit; Strep A Swab Test Strip
EASY HEALTHCARE CORPORATION
ARST-100
In Commercial Distribution
- 10850253007731 ()
- 00850253007734 ()
- 30850253007735 ()
- Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
No Description
Biomedica ADI Inc.
832
In Commercial Distribution
- 00850201006079 ()
832
- Heparin anti-Xa IVD, kit, chromogenic
ANESTHESIA CIRCUIT - LF
MEDLINE INDUSTRIES, INC.
DYNJAAF6694
In Commercial Distribution
- 10889942747184 ()
- 40889942747185 ()
DYNJAAF6694
- General surgical procedure kit, non-medicated, single-use
ANESTHESIA CIRCUIT PEDS-LF
MEDLINE INDUSTRIES, INC.
DYNJAP6184A
In Commercial Distribution
- 10889942733019 ()
- 40889942733010 ()
DYNJAP6184A
- General surgical procedure kit, non-medicated, single-use
ANESTHESIA CIRCUIT - LF
MEDLINE INDUSTRIES, INC.
DYNJAA10626
In Commercial Distribution
- 10889942732166 ()
- 40889942732167 ()
DYNJAA10626
- General surgical procedure kit, non-medicated, single-use
ANESTHESIA CIRCUIT ADULT
MEDLINE INDUSTRIES, INC.
DYNJAA10629
In Commercial Distribution
- 10889942747573 ()
- 40889942747574 ()
DYNJAA10629
- General surgical procedure kit, non-medicated, single-use
No Description
BIOGENEX LABORATORIES
MU113-UC
In Commercial Distribution
- 00850646007471 ()
- Total Volume: 1 Milliliter
MU113-UC
- CD45RO cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
HK092-5KE
In Commercial Distribution
- 00850646007327 ()
HK092-5KE
- Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry
No Description
BIOGENEX LABORATORIES
AM322-5M
In Commercial Distribution
- 00850646007198 ()
- Total Volume: 6 Milliliter
AM322-5M
- CD3 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
AM368-5MSG
In Commercial Distribution
- 00850646007143 ()
- Total Volume: 1 Milliliter
AM368-5MSG
- Estrogen (oestrogen)/progesterone receptor IVD, antibody
No Description
BIOGENEX LABORATORIES
AM328-5MSG
In Commercial Distribution
- 00850646007129 ()
- Total Volume: 1 Milliliter
AM328-5MSG
- Progesterone receptor IVD, antibody
No Description
BIOGENEX LABORATORIES
MU368-5UC
In Commercial Distribution
- 00850646007112 ()
- Total Volume: 0.5 Milliliter
MU368-5UC
- Estrogen (oestrogen)/progesterone receptor IVD, antibody