Other products from "SIEMENS HEALTHCARE DIAGNOSTICS INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00842768039010 10642445 DF150 Alkaline Phosphatase Flex® reagent cartridge, 360 tests CJO ALPHA-NAPHTHYL PHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES Dimension® Flex® reagent cartridge ALPI
2 00842768037740 10706480 RF634 Dimension® EXL™ Total Vitamin D, 200 tests (4x50) MRG SYSTEM, TEST, VITAMIN D Dimension® EXL™ Total Vitamin D
3 00842768037214 10636928 778041.931 Dimension® EXL™ 200 System JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Dimension® EXL™ 200 Integrated Chemistry System
4 00842768034138 10470441 9R529UL Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 DKB,DIF CALIBRATORS, DRUG MIXTURE,DRUG MIXTURE CONTROL MATERIALS 1 Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1
5 00842768033322 10636333 KC470 DGTX Calibrator, 2x5x5.0mL JIT CALIBRATOR, SECONDARY 2 Dimension Vista® DGTX CAL
6 00842768030413 10484429 K800A V-LYTE Integrated Multisensor CEM,JGS,CGZ ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, IO ELECTRODE, ION SPECIFIC, POTASSIUM,ELECTRODE, ION SPECIFIC, SODIUM,ELECTRODE, ION-SPECIFIC, CHLORIDE 2 Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl-
7 00842768030024 10472176 778021.931 Dimension® EXL with LM system JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Dimension® EXL™ with LM Integrated Chemistry System
8 00842768029912 10464526 RF623 LOCI N-terminal Pro-Brain Natriuretic Peptide Flex® reagent cartridge, 120 tests NBC TEST,NATRIURETIC PEPTIDE Dimension® EXL™ LOCI® Module Flex® reagent cartridge NTP
9 00842768029332 10488446 KC605 LOCI 7 Calibrator, 2x5x2mL JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 Dimension Vista® LOCI 7 CAL
10 00842768028915 10472099 KS860 Small Sample Container (SSC), 1000 Pieces JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE Dimension Vista® Small Sample Container (SSC)
11 00842768027307 11306492 11306492 ADVIA 120/2120/2120i Vent Line Wash Kit JCB DETERGENT 1 ADVIA 120/2120/2120i Vent Line Wash Kit
12 00842768025556 10464510 DF32 Creatine Kinase MB Flex® reagent cartridge, 120 tests CGS NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES Dimension® Flex® reagent cartridge MBI
13 00842768025112 10464321 K6423A NT-proBNP Flex® reagent cartridge, 80 Tests NBC TEST,NATRIURETIC PEPTIDE Dimension Vista® Flex® reagent cartridge PBNP
14 00842768023453 10445476 9Q229 Emit® II Plus Methaqualone Assay labeled with the Beckman Coulter® name KXS RADIOIMMUNOASSAY, METHAQUALONE 2 Emit® II Plus Methaqualone Assay
15 00842768023354 10445415 9B229 Emit® II Plus Opiate Assay labeled with the Beckman Coulter® name DJG ENZYME IMMUNOASSAY, OPIATES 2 Emit® II Plus Opiate Assay
16 00842768022111 10464331 DF306 Sirolimus Flex® reagent cartridge, 80 tests NRP Sirolimus test system Dimension® Flex® reagent cartridge SIRO
17 00842768022050 10459408 DF22 Ethyl Alcohol Flex® reagent cartridge, 120 tests DIC ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD Dimension® Flex® reagent cartridge ETOH
18 00842768016653 10445138 K6444 Folate Flex® reagent cartridge, 120 tests CGN ACID, FOLIC, RADIOIMMUNOASSAY Dimension Vista® Flex® reagent cartridge FOL
19 00842768016455 10445187 KC510 Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL DKB CALIBRATORS, DRUG MIXTURE 2 Dimension Vista® UDAT CAL
20 00842768016028 10444897 RF434 CardioPhase® high sensitivity CRP Flex® reagent cartridge, 120 tests NQD CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL Dimension CardioPhase high sensitivity CRP Flex reagent cartridge
21 00842768015731 10445104 K6412 Thyroid Stimulating Hormone Flex® reagent cartridge, 960 Tests JLW RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE Dimension Vista® Flex® reagent cartridge TSH
22 00842768015618 10445160 K1023 Calcium Flex® reagent cartridge, 1320 tests CIC CRESOLPHTHALEIN COMPLEXONE, CALCIUM Dimension Vista® Flex® reagent cartridge CA
23 00842768015496 10445102 K6075 Thyronine Uptake Flex® reagent cartridge, 160 tests KHQ RADIOASSAY, TRIIODOTHYRONINE UPTAKE Dimension Vista® Flex® reagent cartridge TU
24 00842768015328 10445097 K6420 Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 tests JHY COLORIMETRIC METHOD, CPK OR ISOENZYMES Dimension Vista® Flex® reagent cartridge MMB
25 00842768015281 10445132 K4113 Lidocaine Flex® reagent cartridge, 60 tests KLR ENZYME IMMUNOASSAY, LIDOCAINE Dimension Vista® Flex® reagent cartridge LIDO
26 00842768015199 10445106 K6416 Free Triiodothyronine Flex® reagent cartridge, 120 tests CDP RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE Dimension Vista® Flex® reagent cartridge FT3
27 00842768015090 10445143 K1027 Cholesterol Flex® reagent cartridge, 600 tests CHH ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL Dimension Vista® Flex® reagent cartridge CHOL
28 00842768014352 10445423 9D039UL Syva® Emit® II Plus Barbiturate Assay - 28 mL Kit KLT ENZYME IMMUNOASSAY, CARBAMAZEPINE 2 Syva® Emit® II Plus Barbiturate Assay
29 00842768014345 10445418 9C039UL Syva® Emit® II Plus Amphetamines Assay - 29 mL kit DKZ ENZYME IMMUNOASSAY, AMPHETAMINE 2 Syva® Emit® II Plus Amphetamines Assay
30 00842768014338 10445414 9B039UL Syva® Emit® II Plus Opiate Assay - 29 mL Kit DJG ENZYME IMMUNOASSAY, OPIATES 2 Syva® Emit® II Plus Opiate Assay
31 00842768014086 10445042 D828 Cuvette Cartridge - Dimension® - 1 Cartridge JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Dimension® Cuvette Cartridge
32 00842768014024 10444872 S640 Quiklyte Diluent Check, 60mL CGZ,JGS,JFL,CEM ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,PH RATE MEASUR ELECTRODE, ION-SPECIFIC, CHLORIDE,ELECTRODE, ION SPECIFIC, SODIUM,PH RATE MEASUREMENT, CARBON-DIOXIDE,ELECTRODE, ION SPECIFIC, POTASSIUM 2 Dimension® QuikLYTE® Integrated Multisensor Diluent Check
33 00842768013911 10444914 RF530 Human Chorionic Gonadotropin Flex® reagent cartridge, 120 tests DHA SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN Dimension Human Chorionic Gonadotropin Flex reagent cartridge
34 00842768013843 10444907 RF422A Myoglobin Flex® reagent cartridge, 120 tests DDR MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge MYO
35 00842768013775 10445035 RD703 Sample Probe Cleaner, 1x1 Liter JJE,JMG ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,Radioimmunoassay ( ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE,Radioimmunoassay (two-site solid phase), ferritin 1 Dimension® Sample Probe Cleaner
36 00842768013720 10445024 RC422 Myoglobin Calibrator, 2x5x1mL JIT CALIBRATOR, SECONDARY Dimension® MYO Calibrator
37 00842768005848 10444924 DF94A Urine Phencyclidine Screen Flex® reagent cartridge, 80 tests LCM Enzyme immunoassay, phencyclidine Dimension® Flex® reagent cartridge PCP
38 00842768005527 10444894 DF37 C-Reactive Protein Flex® reagent cartridge, 120 tests DCK C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL Dimension® Flex® reagent cartridge CRP
39 00842768005367 10444939 DF132 Lithium Flex® reagent cartridge, 80 tests JIH FLAME PHOTOMETRY, LITHIUM Dimension® Flex® reagent cartridge LI
40 00842768005275 10444948 DF11 Acid Phosphatase Flex® reagent cartridge, 120 tests CKE Acid phosphatase, thymolphthale inmonophosphate Dimension® Flex® reagent cartridge ACP
41 00842768005268 10444934 DF108 Cyclosporine Extended Range Flex® reagent cartridge, 80 tests MKW CYCLOSPORINE Dimension® Flex® reagent cartridge CSAE
42 00842768005183 10445025 DC50 Prealbumin Calibrator, 2x5x1mL JIT CALIBRATOR, SECONDARY Dimension® PALB Calibrator
43 00842768005091 10444993 DC31 Total Protein/Albumin Calibrator, 2x3x2mL JIX CALIBRATOR, MULTI-ANALYTE MIXTURE Dimension® TP/ALB Calibrator
44 00842768005084 10444988 DC30 C-Reactive Protein Calibrator, 2x5x1mL DCK C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL Dimension® CRP Calibrator
45 00842768004445 10445064 CCANS Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube Stratus® CS STAT Fluorometric Analyzer Sarstedt cannula holds the stoppered tube in the sample manager. JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES Stratus® CS STAT Fluorometric Analyzer Cannula
46 00842768004438 10445063 CCANBD For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tube For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer. JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES Stratus® CS STAT Fluorometric Analyzer Cannula
47 00630414600284 10995715 10995715 Vitamin B12 (VB12) Atellica IM - RGT 500T CDD RADIOASSAY, VITAMIN B12 Atellica IM VB12
48 00842768001888 10445424 9D129UL Syva® Emit® II Plus Barbiturate Assay - 1 L Kit KLT ENZYME IMMUNOASSAY, CARBAMAZEPINE 2 Syva® Emit® II Plus Barbiturate Assay
49 00842768001871 10445422 9D029UL Syva® Emit® II Plus Barbiturate Assay - 115 mL Kit KLT ENZYME IMMUNOASSAY, CARBAMAZEPINE 2 Syva® Emit® II Plus Barbiturate Assay
50 00842768001864 10445421 9C329UL Syva® Emit® II Plus Amphetamines Assay - 1L Kit DKZ ENZYME IMMUNOASSAY, AMPHETAMINE 2 Syva® Emit® II Plus Amphetamines Assay
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
30 00380740191825 06R8610 06R8610 SARS-CoV-2 IgG Control Kit ARCHITECT ABBOTT LABORATORIES
31 00380740191818 06R8601 06R8601 SARS-CoV-2 IgG Calibrator Kit ARCHITECT ABBOTT LABORATORIES
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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