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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011325 ()
FL2SP

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011295 ()
FL2-30

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011288 ()
FL1-30

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011271 ()
FL12-60

  • HLA class I & II antibody screening IVD, kit, multiplex
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)
INTENDED USE For the detection and semi-quantitation of IgM 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 IgM 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 IgM, 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 IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product package insert.
CORGENIX MEDICAL CORPORATION
13371
In Commercial Distribution

  • 00855360006182 ()
13371

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only. SUMMARY AND EXPLANATION OF THE I 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 IgG 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 s 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/plasma proteins by washing, antibodies specific for human IgG, 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 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 IgG anti-β2GPl antibody concentrations expressed in G units.. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert.
CORGENIX MEDICAL CORPORATION
13370
In Commercial Distribution

  • 00855360006175 ()
13370

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE For the detection and semi-quantitation of IgM 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 IgM 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 IgM, 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 IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert.
CORGENIX MEDICAL CORPORATION
038-001
In Commercial Distribution

  • 00855360006168 ()
038-001

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only. 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 IgG 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 IgG, 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 IgG anti-β2GPl antibody concentrations expressed in G units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert.
CORGENIX MEDICAL CORPORATION
037-001
In Commercial Distribution

  • 00855360006151 ()
037-001

  • Anticardiolipin-B2-glycoprotein I 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 Use Only. 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
039-001
In Commercial Distribution

  • 00855360006144 ()
039-001

  • Anticardiolipin-B2-glycoprotein I complex 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-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 Total IGF-I enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of IGF-I in serum, plasma and other biological fluids. This assay is intended for in vitro Diagnostic Use Only.
Ansh Labs, LLC
AL-121
In Commercial Distribution

  • 00853592008295 ()
AL-121

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
The Total IGF-I enzyme linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of IGF-I in serum, plasma and other biological fluids. This assay is intended for in vitro diagnostic use only.
Ansh Labs, LLC
AL-121-i
In Commercial Distribution

  • 00853592008066 ()
AL-121-i

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
IGF-1 ELISA
Diasource Immunoassays S.A. SA
KAP1581
In Commercial Distribution

  • 05400569000209 ()


  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin-like Growth Factor 1, IGF-1, in serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4140
Not in Commercial Distribution

  • 00404847441406 ()
EIA-4140

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-1561
Not in Commercial Distribution

  • 00404847415612 ()
EIA-1561

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
IGF-I - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381403
In Commercial Distribution

  • 00630414964041 ()
LKGF1

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
IGF-I - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381448
In Commercial Distribution

  • 00630414961538 ()
L2KGF2

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin-like Growth Factor 1, IGF-1, in serum.
DRG International Inc
EIA-4140
In Commercial Distribution

  • 00840239041401 ()
EIA-4140

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)
DRG International Inc
EIA-1561
In Commercial Distribution

  • 00840239015617 ()
EIA-1561

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN SPA
319133
In Commercial Distribution

  • 08056771200172 ()


  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM
INSTRUMENTATION LABORATORY COMPANY
0009802016
In Commercial Distribution

  • 08426950496984 ()
0009802016

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG
INSTRUMENTATION LABORATORY COMPANY
0009802012
In Commercial Distribution

  • 08426950496977 ()
0009802012

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-3900
In Commercial Distribution

  • 05060169690288 ()


  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
The DRG IGF-1 600 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin-like Growth Factor 1, IGF-1, in serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-4140
In Commercial Distribution

  • 04048474041408 ()
EIA-4140

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
The DRG Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Progesterone in serum or plasma (EDTA, lithium heparin or citrate plasma)
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-1561
In Commercial Distribution

  • 04048474015614 ()
EIA-1561

  • Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
DSI+II
In Commercial Distribution

  • 10888234500193 ()
DSI+II

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
For Use with Factor VIII Antibody Screen and PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
403622
In Commercial Distribution

  • 10888234500407 ()
403622

  • HLA class I antibody screening IVD, reagent
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
303456
In Commercial Distribution

  • 10888234500186 ()
303456

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
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