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AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test
Abbott Ireland Diagnostics
06R8720
In Commercial Distribution
- 00380740191863 ()
06R8720
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
No Description
FUJIREBIO INC.
226964
In Commercial Distribution
- 04987270226964 ()
- Size Type = Tests Per Kit; Size Unit = 3000; Unit of Measure = Tests
PH3000
- Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
No Description
FUJIREBIO INC.
235041
In Commercial Distribution
- 04987270235041 ()
- Size Type = Units per kit; Units = 2; Unit of Measure = 2mL
- Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests
- Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
MONOBIND, INC.
11725-300
In Commercial Distribution
- 00816870023649 ()
- Width: 7.75 Inch
11725-300B
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
MONOBIND, INC.
11725-300
In Commercial Distribution
- 00816870023632 ()
- Width: 7.75 Inch
11725-300A
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
The Access SARS-CoV-2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate). The Access SARS-CoV-2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The Access SARS-CoV-2 IgM should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
The Access SARS-CoV-2 IgM assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58957
In Commercial Distribution
- 15099590738617 ()
C58957
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA M
In Commercial Distribution
- 00850487007418 ()
Q01-480
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA M
In Commercial Distribution
- 00850487007173 ()
Q01-480
- Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QMedix™ Lyme IgG/IgM ELISA
This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi in a clinical specimen, using an enzyme immunoassay (EIA) method.
Diagnostic Automation, Inc.
DACD1423-55
In Commercial Distribution
- 00850054026378 ()
- 96 Tests
1423-55
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Alkaline Phosphatase Developing Solution, 110mL
MARDX DIAGNOSTICS, INC.
44-5017
In Commercial Distribution
- 05391516747707 ()
44-5017
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)