No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740193867 | 06S6130 | 06S6130 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test | QKO | Reagent, coronavirus serological | Alinity | |
2 | 00380740193843 | 06S6120 | 06S6120 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test | QKO | Reagent, coronavirus serological | Alinity | |
3 | 00380740193829 | 06S6110 | 06S6110 | AdviseDx SARS-CoV-2 IgG II Control Kit | QKO | Reagent, coronavirus serological | Alinity | |
4 | 00380740193805 | 06S6101 | 06S6101 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | QKO | Reagent, coronavirus serological | Alinity | |
5 | 00380740193782 | 06S6030 | 06S6030 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
6 | 00380740193768 | 06S6020 | 06S6020 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
7 | 00380740193744 | 06S6010 | 06S6010 | AdviseDx SARS-CoV-2 IgG II Control Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
8 | 00380740112424 | 07K68-35 | 07K6835 | ARCHITECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
9 | 00380740112400 | 3P36-35 | 03P3635 | ARCHITECT AFP Reagent Kit | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
10 | 00380740105433 | 1L82-36 | 01L8236 | ARCHITECT AUSAB Reagent | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
11 | 00380740105426 | 1L82-26 | 01L8226 | ARCHITECT AUSAB Reagent | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
12 | 00380740105419 | 1L82-13 | 01L8213 | ARCHITECT AUSAB Controls | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
13 | 00380740105402 | 1L82-03 | 01L8203 | ARCHITECT AUSAB Calibrators | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | ARCHITECT |
14 | 00380740081317 | 3P36-25 | 03P3625 | ARCHITECT AFP Reagent Kit | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
15 | 00380740081294 | 3P36-10 | 03P3610 | ARCHITECT AFP Controls | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
16 | 00380740081287 | 3P36-01 | 03P3601 | ARCHITECT AFP Calibrators | LOK | KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS | 3 | ARCHITECT |
17 | 00380740014582 | 07K68-32 | 07K6832 | ARCHITECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
18 | 00380740014575 | 07K68-27 | 07K6827 | ARCHTECT CEA Reagent kit | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
19 | 00380740014551 | 07K68-12 | 07K6812 | ARCHITECT CEA Controls | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
20 | 00380740014544 | 07K68-02 | 07K6802 | ARCHITECT CEA Calibrators | DHX | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN | 2 | ARCHITECT |
21 | 00380740013066 | 7D82-50 | 07D8250 | ARCHITECT Multi -Assay Manual Diluent | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
22 | 00380740009786 | 06E2365 | 06E2365 | ARCHITECT PRE TRIGGER SOLUTION | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
23 | 00380740009625 | 6C55-60 | 06C5560 | ARCHITECT TRIGGER SOLUTION | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
24 | 00380740009618 | 6C54-88 | 06C5488 | ARCHITECT CONCENTRATED WASH BUFFER (10L) | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
25 | 00380740009601 | 6C54-58 | 06C5458 | ARCHITECT CONCENTRATED WASH BUFFER | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | ARCHITECT |
26 | 00380740009021 | 6C07-27 | 06C0727 | ARCHITECT Free PSA Reagent Kit | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
27 | 00380740009014 | 6C07-10 | 06C0710 | ARCHITECT Free PSA Controls | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
28 | 00380740009007 | 6C07-01 | 06C0701 | ARCHITECT Free PSA Calibrators | MTG | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCE TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS | 3 | ARCHITECT |
29 | 00380740008994 | 6C06-35 | 06C0635 | ARCHITECT Total PSA Reagent Kit | JJX,JJE,JIS,LTJ,MTF | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,CALIBRATOR, PRIMARY,PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER | 1 | ARCHITECT |
30 | 00380740008987 | 6C06-27 | 06C0627 | ARCHITECT Total PSA Reagent Kit | LTJ,JJX,JIS,JJE,MTF | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECI PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS,SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED),CALIBRATOR, PRIMARY,ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROSTATE CANCER | 1 | ARCHITECT |
31 | 00380740193720 | 06S6001 | 06S6001 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
32 | 00380740192167 | 06R8730 | 06R8730 | AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
33 | 00380740192099 | 06R9130 | 06R9130 | AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test | QKO | Reagent, coronavirus serological | Alinity | |
34 | 00380740192082 | 06R9120 | 06R9120 | AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test | QKO | Reagent, coronavirus serological | Alinity | |
35 | 00380740192075 | 06R9110 | 06R9110 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | Alinity | |
36 | 00380740191863 | 06R8720 | 06R8720 | AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
37 | 00380740191856 | 06R8710 | 06R8710 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
38 | 00380740191849 | 06R8701 | 06R8701 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
39 | 00380740174941 | 04V3831 | 04V3831 | Alinity i STAT CK-MB Reagent Kit 1000 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
40 | 00380740174927 | 04V3821 | 04V3821 | Alinity i STAT CK-MB Reagent Kit 200 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
41 | 00380740174910 | 04V3730 | 04V3730 | Alinity i STAT Myoglobin Reagent Kit 1000 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
42 | 00380740174903 | 04V3720 | 04V3720 | Alinity i STAT Myoglobin Reagent Kit 200 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
43 | 00380740172282 | 04V3710 | 04V3710 | Alinity i STAT Myoglobin Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Alinity |
44 | 00380740172275 | 04V3701 | 04V3701 | Alinity i STAT Myoglobin Calibrators | JIS | Calibrator, primary | 2 | Alinity |
45 | 00380740165505 | 04V3810 | 04V3810 | Alinity i STAT CK-MB Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Alinity |
46 | 00380740165482 | 04V3801 | 04V3801 | Alinity i STAT CK-MB Calibrators | JIS | Calibrator, primary | 2 | Alinity |
47 | 00380740158347 | 07P9331 | 07P9331 | Alinity i Free PSA Reagent Kit 1000 Tests | MTG | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate ca Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions | 3 | Alinity |
48 | 00380740158330 | 07P9321 | 07P9321 | Alinity i Free PSA Reagent Kit 200 Tests | MTG | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate ca Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions | 3 | Alinity |
49 | 00380740158323 | 07P9231 | 07P9231 | Alinity i Total PSA Reagent Kit 1200 Tests | MTF | Total, prostate specific antigen (noncomplexed & complexed) for detection of pro Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | 3 | Alinity |
50 | 00380740158316 | 07P9221 | 07P9221 | Alinity i Total PSA Reagent Kit 200 Tests | MTF | Total, prostate specific antigen (noncomplexed & complexed) for detection of pro Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer | 3 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05700571113011 | K1919 | SARS-CoV-2 IgG ELISA Kit | SARS-CoV-2 IgG ELISA Kit | AGILENT TECHNOLOGIES, INC. | |
2 | 05060169695962 | IS-ID6502 | IDS SARS-COV-2 IgG | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
3 | 04049016150244 | EI 2606-9601-20 G | Anti-SARS-CoV-2 S1 Curve ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
4 | 04049016145554 | EI 2606-9601 G | Anti-SARS-CoV-2 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
5 | 04049016145547 | EI 2606-9601 A | Anti-SARS-CoV-2 ELISA (IgA) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
6 | 00682607200979 | L031-11711 | 200979 | Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25) | ACON SARS-CoV-2 IgG/IgM Rapid Test | ACON LABORATORIES, INC. |
7 | 00630414607139 | 11417771 | K7771 | Vista COV2G Assay | Vista COV2G Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00630414607030 | 11417770 | RF870 | Dimension CV2G Assay | Dimension CV2GAssay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414605500 | 11417414 | K7414 | Vista COV2T Assay | Vista COV2T Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414605494 | 11417413 | KC813 | DV/DM COV2T/CV2T CAL | DV/DM COV2T/CV2T CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00630414605425 | 11417415 | KC815 | DV/DM COV2T/CV2T POS/NEG CTRL | DV/DM COV2T/CV2T POS/NEG CTRL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
12 | 00630414605418 | 11417412 | RF812 | Dimension CV2T Assay | Dimension CV2T Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
13 | 00380740193867 | 06S6130 | 06S6130 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
14 | 00380740193843 | 06S6120 | 06S6120 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
15 | 00380740193829 | 06S6110 | 06S6110 | AdviseDx SARS-CoV-2 IgG II Control Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
16 | 00380740193805 | 06S6101 | 06S6101 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
17 | 00380740193782 | 06S6030 | 06S6030 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
18 | 00380740193768 | 06S6020 | 06S6020 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
19 | 00380740193744 | 06S6010 | 06S6010 | AdviseDx SARS-CoV-2 IgG II Control Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
20 | 00380740193720 | 06S6001 | 06S6001 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
21 | 00380740192167 | 06R8730 | 06R8730 | AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
22 | 00380740192150 | 06R8630 | 06R8630 | SARS-CoV-2 IgG Reagent Kit 500 Tests | ARCHITECT | ABBOTT LABORATORIES |
23 | 00380740192136 | 06R9030 | 06R9030 | SARS-CoV-2 IgG Reagent Kit 1000 Tests | Alinity | ABBOTT LABORATORIES |
24 | 00380740192129 | 06R9020 | 06R9020 | SARS-CoV-2 IgG Reagent Kit 200 Tests | Alinity | ABBOTT LABORATORIES |
25 | 00380740192112 | 06R9010 | 06R9010 | SARS-CoV-2 IgG Control Kit | Alinity | ABBOTT LABORATORIES |
26 | 00380740192105 | 06R9001 | 06R9001 | SARS-CoV-2 IgG Calibrator Kit | Alinity | ABBOTT LABORATORIES |
27 | 00380740192099 | 06R9130 | 06R9130 | AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
28 | 00380740192082 | 06R9120 | 06R9120 | AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
29 | 00380740192075 | 06R9110 | 06R9110 | AdviseDx SARS-CoV-2 IgM Control Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
30 | 00380740192068 | 06R9101 | 06R9101 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
31 | 00380740191863 | 06R8720 | 06R8720 | AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
32 | 00380740191856 | 06R8710 | 06R8710 | AdviseDx SARS-CoV-2 IgM Control Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
33 | 00380740191849 | 06R8701 | 06R8701 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
34 | 00380740191832 | 06R8620 | 06R8620 | SARS-CoV-2 IgG Reagent Kit 100 Tests | ARCHITECT | ABBOTT LABORATORIES |
35 | 00380740191825 | 06R8610 | 06R8610 | SARS-CoV-2 IgG Control Kit | ARCHITECT | ABBOTT LABORATORIES |
36 | 00380740191818 | 06R8601 | 06R8601 | SARS-CoV-2 IgG Calibrator Kit | ARCHITECT | ABBOTT LABORATORIES |
37 | M90171108B0 | 71108B | 71108B | QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one s QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus. | QuickProfile™ 2019-nCoV IgG/IgM Antibody Test | LUMIQUICK DIAGNOSTICS, INC. |
38 | 15099590742768 | C69059 | C69059 | The Access SARS-CoV-2 IgG II QC is intended for monitoring system performance of 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. | Access SARS-CoV-2 IgG II QC | BECKMAN COULTER, INC. |
39 | 15099590742751 | C69058 | C69058 | The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SA The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. | Access SARS-CoV-2 IgG II Calibrator | BECKMAN COULTER, INC. |
40 | 15099590742744 | C69057 | C69057 | The Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent 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. | Access SARS-CoV-2 IgG II | BECKMAN COULTER, INC. |
41 | 15099590738662 | C58964 | C58964 | The Access SARS-CoV-2 IgG QC is intended for monitoring system performance of th 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. | Access SARS-CoV-2 IgG QC | BECKMAN COULTER, INC. |
42 | 15099590738655 | C58963 | C58963 | The Access SARS-CoV-2 IgG Calibrators are intended to calibrate the Access SARS- 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. | Access SARS-CoV-2 IgG Calibrator | BECKMAN COULTER, INC. |
43 | 15099590738648 | C58961 | C58961 | The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent imm 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. | Access SARS-CoV-2 IgG | BECKMAN COULTER, INC. |
44 | 15099590738631 | C58959 | C58959 | The Access SARS-CoV-2 IgM QC is intended for monitoring system performance of th 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. | Access SARS-CoV-2 IgM QC | BECKMAN COULTER, INC. |
45 | 15099590738624 | C58958 | C58958 | The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS- 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. | Access SARS-CoV-2 IgM Calibrator | BECKMAN COULTER, INC. |
46 | 15099590738617 | C58957 | C58957 | The Access SARS-CoV-2 IgM is a paramagnetic particle, chemiluminescent immunoass 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. | Access SARS-CoV-2 IgM | BECKMAN COULTER, INC. |
47 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | FastPack SARS-CoV-2 IgG | QUALIGEN INC. |
48 | 10758750034581 | 6199976 | 6199976 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
49 | 10758750034567 | 6199975 | 6199975 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
50 | 10758750034420 | 6199961 | 6199961 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |