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The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG assay 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. 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 IgG assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58961
In Commercial Distribution
- 15099590738648 ()
C58961
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate) for use on the Access Family of Immunoassay Systems only.
The Access SARS-CoV-2 IgM calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58958
In Commercial Distribution
- 15099590738624 ()
C58958
- SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibrator
No Description
Hologic, Inc.
Procleix System Fluid Preservative
Not in Commercial Distribution
- 15420045500709 ()
301175
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS-CoV-2 IgG assay for the in vitro qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Family of Immunoassay Systems only.
The Access SARS-CoV-2 IgG Calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C58963
In Commercial Distribution
- 15099590738655 ()
C58963
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
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
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
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution
- 06975031821273 ()
- Complete upper denture
- Complete lower denture
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution
- 06975031821259 ()
- Partial denture
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution
- 06975031821242 ()
- Partial denture
No Description
Beijing Yingguan Dental Technology Co., Ltd.
/
In Commercial Distribution
- 06975031821228 ()
- Root canal post kit