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The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG II assay using the Access Immunoassay Systems only.
The Access SARS-CoV-2 IgG II QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69059
In Commercial Distribution
- 15099590742768 ()
C69059
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of the Access SARS-CoV-2 IgG assay. The Access SARS-CoV-2 IgG QC is for use on the Access Family of Immunoassay Systems only.
The Access SARS-CoV-2 IgG QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58964
In Commercial Distribution
- 15099590738662 ()
C58964
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
The Access SARS-CoV-2 IgM QC is intended for monitoring system performance of the Access SARS-CoV-2 IgM assay. The Access SARS-CoV-2 IgM QC is for use on the Access Family of Immunoassay Systems only.
The Access SARS-CoV-2 IgM QC are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58959
In Commercial Distribution
- 15099590738631 ()
C58959
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, control
OSOM COVID-19 Antigen Control Kit
SEKISUI DIAGNOSTICS, LLC
1068
In Commercial Distribution
- 00742860000034 ()
- 10742860000031 ()
1068
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
ADVIA Centaur® Zika IgM Assay
Siemens Healthcare Diagnostics Inc.
11200103
Not in Commercial Distribution
- 00630414170862 ()
11200103
- Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Vista COV2G Assay
Siemens Healthcare Diagnostics Inc.
11417771
Not in Commercial Distribution
- 00630414298382 ()
- 00630414607139 ()
K7771
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Dimension CV2G Assay
Siemens Healthcare Diagnostics Inc.
11417770
Not in Commercial Distribution
- 00630414298375 ()
- 00630414607030 ()
RF870
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Vista COV2T Assay
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution
- 00630414297613 ()
- 00630414605500 ()
K7414
- SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution
- 00630414297590 ()
- 00630414605418 ()
RF812
- SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-4-US
In Commercial Distribution
- 06921963715258 ()
- 06921963712950 ()
- 16921963712957 ()
- SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing