Other products from "ASSURE TECH. (HANGZHOU) CO., LTD."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 06952804830229 1.0 QBF,QAW,PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The C Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The Counter,Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter 2 AssureTech Quick Cup Tests
2 06952804802639 1.0 15 strips, including MOR2000 QBF,QAW,PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV,NFT Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The C Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The Counter,Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter,Test, Amphetamine, Over The Counter 2 AssureTech Quick Cup Tests
3 06952804802615 1.0 15 strips, including MOR300 QBF,QAW,PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV,NFT Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The C Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The Counter,Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter,Test, Amphetamine, Over The Counter 2 AssureTech Quick Cup Tests
4 06952804801847 1.0 JHI Visual, Pregnancy Hcg, Prescription Use 2 HCG Pregnancy Serum/Urine Combo Test Cassette (20/20)
5 06952804801793 1.0 LDJ Enzyme Immunoassay, Cannabinoids 2 Marijuana Panel Dip
6 06952804801427 1.0 DJG,DIO,DKZ Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites, Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Amphetamine 2 Amphetamine/Cocaine/Morphine Panel Dip
7 06952804801397 1.0 DJR,DJG Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates 2 Buprenorphine/Methadone Panel Dip
8 06952804801199 1.0 LDJ Enzyme Immunoassay, Cannabinoids 2 Marijuana Strip
9 06952804801144 1.0 DKZ Enzyme Immunoassay, Amphetamine 2 Amphetamine Strip
10 06952804830212 1.0 AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, P AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300 QBF,QAW,PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The C Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The Counter,Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter 2 AssureTech Panel Dip Tests
11 06952804802646 1.0 12 Strips, including MOR2000 PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV,NFT Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phen Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter,Test, Amphetamine, Over The Counter 2 AssureTech Panel Dip Tests
12 06952804802622 1.0 15 strips, including MOR2000 QBF,QAW,PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV,NFT Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The C Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The Counter,Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter,Test, Amphetamine, Over The Counter 2 AssureTech Panel Dip Tests
13 06952804802608 1.0 15 Strips, including MOR300 NFT,QBF,QAW,PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV Test, Amphetamine, Over The Counter,Test, Propoxyphene, Over The Counter,Test, T Test, Amphetamine, Over The Counter,Test, Propoxyphene, Over The Counter,Test, Tricyclic Antidepressants, Over The Counter,Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter 2 AssureTech Panel Dip Tests
14 06952804801656 1.0 PTG,NGM,PTH,NFV,NGL,NGG,NFY,NFW,NFT Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Te Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Barbiturate, Over The Counter,Test, Benzodiazepine, Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Amphetamine, Over The Counter 2 AssureTech Panel Dip Tests
15 06952804801434 1.0 DIO,DJG,DKZ Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Amphetamine 2 Amphetamine/Cocaine/Morphine Quick Cup
16 06952804801403 1.0 DJR,DJG Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates 2 Buprenorphine/Methadone Quick Cup
17 06952804801182 1.0 LCM Enzyme Immunoassay, Phencyclidine U Phencyclidine Strip
18 06952804801120 1.0 DJG Enzyme Immunoassay, Opiates 2 Buprenorphine Strip
19 06952804801946 1.0 NFY,NGL,NFW Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Opiates, Over The Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Opiates, Over The Counter,Test, Cannabinoid, Over The Counter 2 OPI/COC/THC Tests Panel
20 06952804801816 1.0 NFV Test, Benzodiazepine, Over The Counter 2 Benzodiazepines Panel Dip
21 06952804801700 1.0 DIS Enzyme Immunoassay, Barbiturate 2 Barbiturate Panel Dip
22 06952804801519 1.0 NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1 Follicle stimulating hormone Rapid Test Strip
23 06952804801168 1.0 DJG Enzyme Immunoassay, Opiates 2 Morphine Strip
24 06952804801755 1.0 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 Cocaine Panel Dip
25 06952804801410 1.0 DJR,DJG Enzyme Immunoassay, Methadone,Enzyme Immunoassay, Opiates 2 Buprenorphine/Methadone Turnkey Split Cup
26 06952804801175 1.0 DJC Thin Layer Chromatography, Methamphetamine 2 Methamphetamine Strip
27 06952804801717 1.0 DJG Enzyme Immunoassay, Opiates 2 Oxycodone Panel Dip
28 06952804801472 1.0 LDJ,LCM,DJC Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Phencyclidine,Thin Layer Ch Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Phencyclidine,Thin Layer Chromatography, Methamphetamine 2 Methamphetamine/Phencyclidine/Marijuana Turnkey Split Cup
29 06952804801441 1.0 DIO,DJG,DKZ Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Opiates, Enzyme Immunoassay, Cocaine And Cocaine Metabolites,Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Amphetamine 2 Amphetamine/Cocaine/Morphine Turnkey Split Cup
30 06952804801298 1.0 DJG,DIS Enzyme Immunoassay, Opiates,Enzyme Immunoassay, Barbiturate 2 Turn-Key Split Cup
31 06952804801205 1.0 HCG-C23 JHI Visual, Pregnancy Hcg, Prescription Use 2 hCG Pregnancy Serum/Urine Combo Test Cassette
32 06952804801090 1.0 JHI Visual, Pregnancy Hcg, Prescription Use 2 hCG Pregnancy Test Cassette
33 06952804801083 1.0 DIS,DJG Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Opiates 2 Panel Dip
34 06952804801830 1.0 JHI Visual, Pregnancy Hcg, Prescription Use 2 hCG Pregnancy Serum/Urine Combo Test Strip(10/20)
35 06952804801151 1.0 DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 Cocaine Strip
36 06952804801892 1.0 MD-U610 AMP1000/BAR300/BZO300/COC300/MET1000/MOR2000/MTD300/OXY100/PCP25/THC50 NFT,LDJ,NGM,PTG,NGL,NGG,NFY,NFV,PTH Test, Amphetamine, Over The Counter,Enzyme Immunoassay, Cannabinoids,Test, Phenc Test, Amphetamine, Over The Counter,Enzyme Immunoassay, Cannabinoids,Test, Phencyclidine (Pcp), Over The Counter,Test, Methadone, Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Benzodiazepine, Over The Counter,Test, Barbiturate, Over The Counter 2 DOA Urine Cup 004
37 06952804801885 1.0 MD-U65 COC300/AMP1000/MET1000/THC50/MOR 2000 LDJ,DJG,DJC,DKZ,DIO Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Thin Layer Chromato Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Opiates,Thin Layer Chromatography, Methamphetamine,Enzyme Immunoassay, Amphetamine,Enzyme Immunoassay, Cocaine And Cocaine Metabolites 2 DOA Urine Cup 004
38 06952804801823 1.0 NGG Test, Methamphetamine, Over The Counter 2 Ecstasy Panel Dip
39 06952804801779 1.0 DJC Thin Layer Chromatography, Methamphetamine 2 Methamphetamine Panel Dip
40 06952804801762 1.0 DJG Enzyme Immunoassay, Opiates 2 Morphine Panel Dip
41 06952804801748 1.0 DKZ Enzyme Immunoassay, Amphetamine 2 Amphetamine Panel Dip
42 06952804801724 1.0 DJG Enzyme Immunoassay, Opiates 2 Buprenorphine Panel Dip
43 06952804801465 1.0 LDJ,LCM,DJC Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Phencyclidine,Thin Layer Ch Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Phencyclidine,Thin Layer Chromatography, Methamphetamine 2 Methamphetamine/Phencyclidine/Marijuana Quick Cup
44 06952804801458 1.0 LDJ,LCM,DJC Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Phencyclidine,Thin Layer Ch Enzyme Immunoassay, Cannabinoids,Enzyme Immunoassay, Phencyclidine,Thin Layer Chromatography, Methamphetamine 2 Methamphetamine/Phencyclidine/Marijuana Panel Dip
45 06952804801236 1.0 Quick Cup 25 Tests/kit DIS,DJG Enzyme Immunoassay, Barbiturate,Enzyme Immunoassay, Opiates 2 Quick Cup
46 06952804801212 1.0 JHI Visual, Pregnancy Hcg, Prescription Use 2 HCG Pregnancy Test Strip
47 06952804802653 1.0 12 strips, including MOR2000 PTH,PTG,NGM,NGL,NGG,NFY,NFW,NFV,NFT Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phen Test, Barbiturate, Over The Counter,Test, Methadone, Over The Counter,Test, Phencyclidine (Pcp), Over The Counter,Test, Opiates, Over The Counter,Test, Methamphetamine, Over The Counter,Test, Cocaine And Cocaine Metabolites, Over The Counter,Test, Cannabinoid, Over The Counter,Test, Benzodiazepine, Over The Counter,Test, Amphetamine, Over The Counter 2 AssureTech Quick Cup Test
48 06952804801809 1.0 NGL Test, Opiates, Over The Counter 2 Morphine300 Panel Dip
49 06952804801786 1.0 LCM Enzyme Immunoassay, Phencyclidine U Phencyclidine Panel Dip
50 06952804801731 1.0 DJR Enzyme Immunoassay, Methadone 2 Methadone Panel Dip
Other products with the same Product Code "QKO"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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.
2 00630414607139 11417771 K7771 Vista COV2G Assay Vista COV2G Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
3 00630414607030 11417770 RF870 Dimension CV2G Assay Dimension CV2GAssay SIEMENS HEALTHCARE DIAGNOSTICS INC.
4 00630414605500 11417414 K7414 Vista COV2T Assay Vista COV2T Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
5 00630414605494 11417413 KC813 DV/DM COV2T/CV2T CAL DV/DM COV2T/CV2T CAL SIEMENS HEALTHCARE DIAGNOSTICS INC.
6 00630414605425 11417415 KC815 DV/DM COV2T/CV2T POS/NEG CTRL DV/DM COV2T/CV2T POS/NEG CTRL SIEMENS HEALTHCARE DIAGNOSTICS INC.
7 00630414605418 11417412 RF812 Dimension CV2T Assay Dimension CV2T Assay SIEMENS HEALTHCARE DIAGNOSTICS INC.
8 00380740193867 06S6130 06S6130 AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test Alinity ABBOTT IRELAND DIAGNOSTICS
9 00380740193843 06S6120 06S6120 AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test Alinity ABBOTT IRELAND DIAGNOSTICS
10 00380740193829 06S6110 06S6110 AdviseDx SARS-CoV-2 IgG II Control Kit Alinity ABBOTT IRELAND DIAGNOSTICS
11 00380740193805 06S6101 06S6101 AdviseDx SARS-CoV-2 IgG II Calibrator Kit Alinity ABBOTT IRELAND DIAGNOSTICS
12 00380740193782 06S6030 06S6030 AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
13 00380740193768 06S6020 06S6020 AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
14 00380740193744 06S6010 06S6010 AdviseDx SARS-CoV-2 IgG II Control Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
15 00380740193720 06S6001 06S6001 AdviseDx SARS-CoV-2 IgG II Calibrator Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
16 00380740192167 06R8730 06R8730 AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
17 00380740192150 06R8630 06R8630 SARS-CoV-2 IgG Reagent Kit 500 Tests ARCHITECT ABBOTT LABORATORIES
18 00380740192136 06R9030 06R9030 SARS-CoV-2 IgG Reagent Kit 1000 Tests Alinity ABBOTT LABORATORIES
19 00380740192129 06R9020 06R9020 SARS-CoV-2 IgG Reagent Kit 200 Tests Alinity ABBOTT LABORATORIES
20 00380740192112 06R9010 06R9010 SARS-CoV-2 IgG Control Kit Alinity ABBOTT LABORATORIES
21 00380740192105 06R9001 06R9001 SARS-CoV-2 IgG Calibrator Kit Alinity ABBOTT LABORATORIES
22 00380740192099 06R9130 06R9130 AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test Alinity ABBOTT IRELAND DIAGNOSTICS
23 00380740192082 06R9120 06R9120 AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test Alinity ABBOTT IRELAND DIAGNOSTICS
24 00380740192075 06R9110 06R9110 AdviseDx SARS-CoV-2 IgM Control Kit Alinity ABBOTT IRELAND DIAGNOSTICS
25 00380740192068 06R9101 06R9101 AdviseDx SARS-CoV-2 IgM Calibrator Kit Alinity ABBOTT IRELAND DIAGNOSTICS
26 00380740191863 06R8720 06R8720 AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test ARCHITECT ABBOTT IRELAND DIAGNOSTICS
27 00380740191856 06R8710 06R8710 AdviseDx SARS-CoV-2 IgM Control Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
28 00380740191849 06R8701 06R8701 AdviseDx SARS-CoV-2 IgM Calibrator Kit ARCHITECT ABBOTT IRELAND DIAGNOSTICS
29 00380740191832 06R8620 06R8620 SARS-CoV-2 IgG Reagent Kit 100 Tests ARCHITECT ABBOTT LABORATORIES
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32 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.
33 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.
34 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.
35 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.
36 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.
37 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.
38 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.
39 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.
40 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.
41 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.
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