SEARCH RESULTS FOR: AT(187 results)
The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative detection of IgG antibodies to SARS-CoV-2 in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate). The Access SARS-CoV-2 IgG II 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. The Access SARS-CoV-2 IgG II should not be used to diagnose or exclude 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 IgG II assay is only for use under the Food and Drug Administration's Emergency Use Authorization.
Beckman Coulter, Inc.
C69057
In Commercial Distribution
- 15099590742744 ()
C69057
- SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
1 Test per kit (L03A-R0645):Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1); 2 Test per kit (L03A-R0745): Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2); 5 Test per kit (L03A-R0845): Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5); 25 Test per kit (L03A-R0945): Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Acon Laboratories, Inc.
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
In Commercial Distribution
- 30810107290041 ()
- 00810107290040 ()
- 00810107290002 ()
- 30810107290034 ()
- 00810107290033 ()
- 60810107290035 ()
- 40810107290024 ()
- 00810107290026 ()
- 10810107290030 ()
- 50810107290014 ()
- 40810107290017 ()
- 00810107290019 ()
- 10810107290016 ()
- 20810107290020 ()
- 10810107290023 ()
- 20810107290037 ()
- 60810107290028 ()
- 60810107290011 ()
- 40810107290031 ()
- 30810107290010 ()
- 50810107290038 ()
- 30810107290027 ()
- 20810107290013 ()
- 70810107290032 ()
- 80810107290039 ()
- 50810107290021 ()
- 80810107290015 ()
L03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945
- Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing
Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25)
Acon Laboratories, Inc.
L031-125P5
In Commercial Distribution
- 20682607660470 ()
- 00682607660476 ()
- 00682607002306 ()
660476
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5)
Acon Laboratories, Inc.
L031-125N5
In Commercial Distribution
- 20682607660289 ()
- 00682607660285 ()
- 00682607002306 ()
660285
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2)
Acon Laboratories, Inc.
L031-125M5
In Commercial Distribution
- 20682607660272 ()
- 00682607660278 ()
- 00682607002306 ()
660278
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1)
Acon Laboratories, Inc.
L031-118B5
In Commercial Distribution
- 10682607660268 ()
- 00682607660261 ()
- 20682607533262 ()
- 20682607660265 ()
- 00682607002306 ()
660261
- SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution
- 20682607200973 ()
- 00682607200979 ()
- 00682607002269 ()
200979
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical