No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05700574034795 | 406PSUB2SB-SI | Microplate Washer Dispenser | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | 406PSUB2SB-SI | |
2 | 05700574033873 | 405LSHTV-SI | Microplate Washer | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | 405LSHTV-SI | |
3 | 05700574026615 | G111424 | IGH BA P20 | MVU | Reagents, specific, analyte | 1 | IGH BA P20 | |
4 | 05700571105597 | IC002 | DuoFLEX Cocktail Anti-CD3 Anti-CD20cy Ready-to-Use (Link) | NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 1 | Dako | |
5 | 05700571101520 | A0566 | Polyclonal Rabbit Anti-Somatostatin | NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 1 | Dako | |
6 | 05700574036966 | SH1FG-SI | Multi-Mode Microplate Reader | JJQ | COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | 1 | SH1FG-SI | |
7 | 05700574036379 | G110470R | SureFISH 8p11.22 FGFR1 5’ BA 515kb 20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 8p11.22 FGFR1 5’ BA 515kb 20 RD | |
8 | 05700574036232 | G110455G | SureFISH 22q11.23 BCR DF 1388kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH 22q11.23 BCR DF 1388kb P20 GR | |
9 | 05700574035983 | G110357G | SureFISH 8q24.3 Chr8qTel 397kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH 8q24.3 Chr8qTel 397kb P20 GR | |
10 | 05700574033293 | G110418G | SureFISH 1q25.2 ABL2 3’ BA 464kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH 1q25.2 ABL2 3’ BA 464kb P20 GR | |
11 | 05700574033170 | G110406R | SureFISH PDGFD BA 3’ BA 350kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH PDGFD BA 3’ BA 350kb P20 RD | |
12 | 05700574033057 | G110394R | SureFISH 18q11.2 SS18 5’ BA 406kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 18q11.2 SS18 5’ BA 406kb P20 RD | |
13 | 05700574032357 | G110324R | SureFISH 1q21.3 CKS1B 386kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 1q21.3 CKS1B 386kb P20 RD | |
14 | 05700574032302 | G110319R | SureFISH 3q29 Chr3qTel 380kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 3q29 Chr3qTel 380kb P20 RD | |
15 | 05700574032111 | G110300R | SureFISH Yp11.31 SRY 131kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH Yp11.31 SRY 131kb P20 RD | |
16 | 05700574032043 | G110293G | SureFISH 19p13.3 TCF3 DF 729kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH 19p13.3 TCF3 DF 729kb P20 GR | |
17 | 05700574031985 | G110287R | SureFISH 8q13.3 NCOA2 DF 700kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 8q13.3 NCOA2 DF 700kb P20 RD | |
18 | 05700574031824 | G110271R | SureFISH Chr18 CEP 711kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH Chr18 CEP 711kb P20 RD | |
19 | 05700574031800 | G110269R | SureFISH Chr15 CEP 265kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH Chr15 CEP 265kb P20 RD | |
20 | 05700574031732 | G110262R | SureFISH Chr3 CEP 592kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH Chr3 CEP 592kb P20 RD | |
21 | 05700574031596 | G110248R | SureFISH Chr8 635kb CEP P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH Chr8 635kb CEP P20 RD | |
22 | 05700574031572 | G110246R | SureFISH 7q31.2 D7S486 200kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 7q31.2 D7S486 200kb P20 RD | |
23 | 05700574031527 | G110241R | SureFISH Xp11.23 TFE3 523kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH Xp11.23 TFE3 523kb P20 RD | |
24 | 05700574031497 | G110238R | SureFISH 1p33 STIL 75kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 1p33 STIL 75kb P20 RD | |
25 | 05700574031459 | G110234R | SureFISH 6p21.32 PHF1 5' BA 355kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 6p21.32 PHF1 5' BA 355kb P20 RD | |
26 | 05700574031428 | G110231R | SureFISH 20p12.2 JAG1 152kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 20p12.2 JAG1 152kb P20 RD | |
27 | 05700574031404 | G110229R | SureFISH 12p13.2 ETV6 505kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 12p13.2 ETV6 505kb P20 RD | |
28 | 05700574031305 | G110219G | SureFISH 8p12 NRG1 5' BA 460kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH 8p12 NRG1 5' BA 460kb P20 GR | |
29 | 05700574031237 | G110212R | SureFISH 11q13.3 CCND1 997kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 11q13.3 CCND1 997kb P20 RD | |
30 | 05700574031077 | G110897B | SureFISH 8q24.3 Chr8qTel 397kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 8q24.3 Chr8qTel 397kb P20 BL | |
31 | 05700574030988 | G110889G | SureFISH Chr2 CEP 448kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH Chr2 CEP 448kb P20 GR | |
32 | 05700574030933 | G110887B | SureFISH Chr21 CEP 653kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH Chr21 CEP 653kb P20 BL | |
33 | 05700574030865 | G110883B | SureFISH Chr11 CEP 798kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH Chr11 CEP 798kb P20 BL | |
34 | 05700574030827 | G110876B | SureFISH 16p13.3 Chr16pTel 428kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 16p13.3 Chr16pTel 428kb P20 BL | |
35 | 05700574030667 | G110867G | SureFISH Chr5 CEP 633kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH Chr5 CEP 633kb P20 GR | |
36 | 05700574030650 | G110867B | SureFISH Chr5 CEP 633kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH Chr5 CEP 633kb P20 BL | |
37 | 05700574030643 | G110866G | SureFISH Chr4 CEP 613kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH Chr4 CEP 613kb P20 GR | |
38 | 05700574030636 | G110866B | SureFISH Chr4 CEP 613kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH Chr4 CEP 613kb P20 BL | |
39 | 05700574030605 | G110864B | SureFISH Chr1 CEP 541kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH Chr1 CEP 541kb P20 BL | |
40 | 05700574030483 | G110854B | SureFISH 7q36.3 Ch7qTel 396kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 7q36.3 Ch7qTel 396kb P20 BL | |
41 | 05700574030445 | G110850B | SureFISH 22q13.33 Chr22qTel 383kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 22q13.33 Chr22qTel 383kb P20 BL | |
42 | 05700574030322 | G110838B | SureFISH 21q22.3 Chr21qTel 394kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 21q22.3 Chr21qTel 394kb P20 BL | |
43 | 05700574030315 | G110837B | SureFISH 11q25 Chr11qTel 398kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 11q25 Chr11qTel 398kb P20 BL | |
44 | 05700574030308 | G110836B | SureFISH 12p13.33 Chr12pTel 407kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 12p13.33 Chr12pTel 407kb P20 BL | |
45 | 05700574030261 | G110833B | SureFISH 9q34.11 ASS1 367kb P20 BL | MVU | Reagents, specific, analyte | 1 | SureFISH 9q34.11 ASS1 367kb P20 BL | |
46 | 05700574030094 | G110750G | SureFISH 7q34 KIAA1549 150kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH 7q34 KIAA1549 150kb P20 GR | |
47 | 05700574030087 | G110749R | SureFISH 8p23.1 GATA4 118kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 8p23.1 GATA4 118kb P20 RD | |
48 | 05700574029968 | G110737G | SureFISH 22q13.33 SHANK3 70kb P20 GR | MVU | Reagents, specific, analyte | 1 | SureFISH 22q13.33 SHANK3 70kb P20 GR | |
49 | 05700574029920 | G110733R | SureFISH 17q21.33 COL1A1 DF 789kb P20 RD | MVU | Reagents, specific, analyte | 1 | SureFISH 17q21.33 COL1A1 DF 789kb P20 RD | |
50 | 05700574026660 | G111931 | IGH CCND1 DF P200 | MVU | Reagents, specific, analyte | 1 | IGH CCND1 DF P200 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04049016150244 | EI 2606-9601-20 G | Anti-SARS-CoV-2 S1 Curve ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
2 | 04049016145554 | EI 2606-9601 G | Anti-SARS-CoV-2 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
3 | 04049016145547 | EI 2606-9601 A | Anti-SARS-CoV-2 ELISA (IgA) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
4 | 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. |
5 | 00630414607139 | 11417771 | K7771 | Vista COV2G Assay | Vista COV2G Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
6 | 00630414607030 | 11417770 | RF870 | Dimension CV2G Assay | Dimension CV2GAssay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00630414605500 | 11417414 | K7414 | Vista COV2T Assay | Vista COV2T Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
8 | 00630414605494 | 11417413 | KC813 | DV/DM COV2T/CV2T CAL | DV/DM COV2T/CV2T CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
9 | 00630414605425 | 11417415 | KC815 | DV/DM COV2T/CV2T POS/NEG CTRL | DV/DM COV2T/CV2T POS/NEG CTRL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
10 | 00630414605418 | 11417412 | RF812 | Dimension CV2T Assay | Dimension CV2T Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
11 | 00380740193867 | 06S6130 | 06S6130 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
12 | 00380740193843 | 06S6120 | 06S6120 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
13 | 00380740193829 | 06S6110 | 06S6110 | AdviseDx SARS-CoV-2 IgG II Control Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
14 | 00380740193805 | 06S6101 | 06S6101 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
15 | 00380740193782 | 06S6030 | 06S6030 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
16 | 00380740193768 | 06S6020 | 06S6020 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
17 | 00380740193744 | 06S6010 | 06S6010 | AdviseDx SARS-CoV-2 IgG II Control Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
18 | 00380740193720 | 06S6001 | 06S6001 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
19 | 00380740192167 | 06R8730 | 06R8730 | AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
20 | 00380740192150 | 06R8630 | 06R8630 | SARS-CoV-2 IgG Reagent Kit 500 Tests | ARCHITECT | ABBOTT LABORATORIES |
21 | 00380740192136 | 06R9030 | 06R9030 | SARS-CoV-2 IgG Reagent Kit 1000 Tests | Alinity | ABBOTT LABORATORIES |
22 | 00380740192129 | 06R9020 | 06R9020 | SARS-CoV-2 IgG Reagent Kit 200 Tests | Alinity | ABBOTT LABORATORIES |
23 | 00380740192112 | 06R9010 | 06R9010 | SARS-CoV-2 IgG Control Kit | Alinity | ABBOTT LABORATORIES |
24 | 00380740192105 | 06R9001 | 06R9001 | SARS-CoV-2 IgG Calibrator Kit | Alinity | ABBOTT LABORATORIES |
25 | 00380740192099 | 06R9130 | 06R9130 | AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
26 | 00380740192082 | 06R9120 | 06R9120 | AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
27 | 00380740192075 | 06R9110 | 06R9110 | AdviseDx SARS-CoV-2 IgM Control Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
28 | 00380740192068 | 06R9101 | 06R9101 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
29 | 00380740191863 | 06R8720 | 06R8720 | AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
30 | 00380740191856 | 06R8710 | 06R8710 | AdviseDx SARS-CoV-2 IgM Control Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
31 | 00380740191849 | 06R8701 | 06R8701 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
32 | 00380740191832 | 06R8620 | 06R8620 | SARS-CoV-2 IgG Reagent Kit 100 Tests | ARCHITECT | ABBOTT LABORATORIES |
33 | 00380740191825 | 06R8610 | 06R8610 | SARS-CoV-2 IgG Control Kit | ARCHITECT | ABBOTT LABORATORIES |
34 | 00380740191818 | 06R8601 | 06R8601 | SARS-CoV-2 IgG Calibrator Kit | ARCHITECT | ABBOTT LABORATORIES |
35 | 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. |
36 | 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. |
37 | 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. |
38 | 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. |
39 | 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. |
40 | 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. |
41 | 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. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | FastPack SARS-CoV-2 IgG | QUALIGEN INC. |
46 | 10758750034581 | 6199976 | 6199976 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
47 | 10758750034567 | 6199975 | 6199975 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
48 | 10758750034420 | 6199961 | 6199961 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
49 | 10758750034413 | 6199960 | 6199960 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
50 | 10758750033409 | 6199924 | 6199924 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |