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 | 00380740192068 | 06R9101 | 06R9101 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | QKO | Reagent, coronavirus serological | Alinity | |
37 | 00380740191863 | 06R8720 | 06R8720 | AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
38 | 00380740191856 | 06R8710 | 06R8710 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
39 | 00380740191849 | 06R8701 | 06R8701 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
40 | 00380740174941 | 04V3831 | 04V3831 | Alinity i STAT CK-MB Reagent Kit 1000 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
41 | 00380740174927 | 04V3821 | 04V3821 | Alinity i STAT CK-MB Reagent Kit 200 Tests | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Alinity |
42 | 00380740174910 | 04V3730 | 04V3730 | Alinity i STAT Myoglobin Reagent Kit 1000 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
43 | 00380740174903 | 04V3720 | 04V3720 | Alinity i STAT Myoglobin Reagent Kit 200 Tests | DDR | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Alinity |
44 | 00380740172282 | 04V3710 | 04V3710 | Alinity i STAT Myoglobin Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Alinity |
45 | 00380740172275 | 04V3701 | 04V3701 | Alinity i STAT Myoglobin Calibrators | JIS | Calibrator, primary | 2 | Alinity |
46 | 00380740165505 | 04V3810 | 04V3810 | Alinity i STAT CK-MB Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Alinity |
47 | 00380740165482 | 04V3801 | 04V3801 | Alinity i STAT CK-MB Calibrators | JIS | Calibrator, primary | 2 | Alinity |
48 | 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 |
49 | 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 |
50 | 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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15099590750954 | 98201 | 98201 | The Access BNP QC Controls are intended for monitoring the performance of the Ac The Access BNP QC Controls are intended for monitoring the performance of the Access BNP test using the Beckman Coulter Access Family of Immunoassay Systems. | Access BNP QC | BECKMAN COULTER, INC. |
2 | 15099590707118 | DxA 5000 | DxA 5000 | DxA 5000 | BECKMAN COULTER, INC. | |
3 | 15099590677398 | B83877 | B83877 | The Access Ostase QC is intended for monitoring system performance of the Access The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | Access Ostase QC | BECKMAN COULTER, INC. |
4 | 15099590677381 | B83876 | B83876 | The Access Ostase Calibrators are intended to calibrate the Access Ostase assay The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. | Access Ostase Calibrators | BECKMAN COULTER, INC. |
5 | 15099590672324 | Power Express | B36352 | Power Express | Power Express | BECKMAN COULTER, INC. |
6 | 15099590671501 | B63285 | B63285 | The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3r The Access TSH (3rd IS) Calibrators are intended to calibrate the Access TSH (3rd IS) assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. | Access TSH (3rd IS) Calibrators | BECKMAN COULTER, INC. |
7 | 15099590604479 | Power Processor PowerCel | A36587 | Power Processor PowerCel | Power Processor PowerCel | BECKMAN COULTER, INC. |
8 | 15099590591960 | Power Processor Sample Handling System | A11036 | Power Processor Sample Handling System | Power Processor Sample Handling System | BECKMAN COULTER, INC. |
9 | 15099590583996 | Power Link | B05033 | Power Link | Power Link | BECKMAN COULTER, INC. |
10 | 15099590575304 | 33825 | 33825 | The Access HYPERsensitive hTSH calibrators (BSA matrix) are intended to calibrat The Access HYPERsensitive hTSH calibrators (BSA matrix) are intended to calibrate the Access HYPERsensitive hTSH assay for the quantitative determination of hTSH levels in human serum and plasma using the Access Immunoassay Systems. | HYPERsensitive hTSH Calibrators | BECKMAN COULTER, INC. |
11 | 15099590575137 | 465365 | 465365 | Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator | IMMAGE | BECKMAN COULTER, INC. |
12 | 15099590233310 | 465915 | 465915 | SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR | Synchron | BECKMAN COULTER, INC. |
13 | 15099590232412 | 386372 | 386372 | The Access CK-MB Calibrators are intended to calibrate the Access CK-MB assay fo The Access CK-MB Calibrators are intended to calibrate the Access CK-MB assay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. | Access CK-MB Calibrators | BECKMAN COULTER, INC. |
14 | 15099590232306 | 37305 | 37305 | The Access Ostase Calibrators are intended to calibrate the Access Ostase assay The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems. | Access Ostase Calibrators | BECKMAN COULTER, INC. |
15 | 15099590232290 | 37309 | 37309 | The Access Ostase QC is intended for monitoring system performance of the Access The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. | Access Ostase QC | BECKMAN COULTER, INC. |
16 | 15099590232108 | 650038 | 650038 | Vigil HbA1c Controls Levels 1 & 2 | Vigil | BECKMAN COULTER, INC. |
17 | 15099590231361 | 33555 | 33555 | The Access Progesterone Calibrators are intended to calibrate the Access Progest The Access Progesterone Calibrators are intended to calibrate the Access Progesterone assay for the quantitative determination of progesterone levels in human serum using the Access Immunoassay Systems. | Access Progesterone Calibrators | BECKMAN COULTER, INC. |
18 | 15099590231101 | 33605 | 33605 | The Access Cortisol Calibrators are intended to calibrate the Access Cortisol as The Access Cortisol Calibrators are intended to calibrate the Access Cortisol assay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. | Access Cortisol Calibrators | BECKMAN COULTER, INC. |
19 | 15099590231095 | 33606 | 33606 | The Access Cortisol Calibrator S0 is intended for use with the Access Cortisol a The Access Cortisol Calibrator S0 is intended for use with the Access Cortisol assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator. | Access Cortisol Calibrator S0 | BECKMAN COULTER, INC. |
20 | 15099590229108 | 387999 | 387999 | The Access Intrinsic Factor Ab QC is intended for monitoring system performance The Access Intrinsic Factor Ab QC is intended for monitoring system performance of the Access Intrinsic Factor Ab assay. | Access Intrinsic Factor Ab QC | BECKMAN COULTER, INC. |
21 | 15099590228705 | 667710 | 667710 | Ultimate -D Bilirubin Control Level 1 | Ultimate | BECKMAN COULTER, INC. |
22 | 15099590225872 | 33805 | 33805 | The Access Total T4 Calibrators are intended to calibrate the Access Total T4 as The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. | Access Total T4 Calibrators | BECKMAN COULTER, INC. |
23 | 15099590225810 | 33885 | 33885 | The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assa The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems. | Access Free T4 Calibrators | BECKMAN COULTER, INC. |
24 | 15099590225353 | 475081 | 475081 | SYNCHRON Systems PAB Calibrator | Synchron | BECKMAN COULTER, INC. |
25 | 15099590225346 | 475089 | 475089 | SYNCHRON Systems MA Calibrator | Synchron | BECKMAN COULTER, INC. |
26 | 15099590223038 | 667720 | 667720 | Ultimate -D Bilirubin Control Level 2 | Ultimate | BECKMAN COULTER, INC. |
27 | 15099590223021 | 667730 | 667730 | Ultimate -D Bilirubin Control Level 3 | Ultimate | BECKMAN COULTER, INC. |
28 | 15099590223014 | 667740 | 667740 | Ultimate -D Bilirubin Control Level 4 | Ultimate | BECKMAN COULTER, INC. |
29 | 15099590210717 | B11057 | B11057 | The Access sTfR QC2 and QC3 is intended for monitoring system performance of the The Access sTfR QC2 and QC3 is intended for monitoring system performance of the Access sTfR assay. | Access sTfR QC2 and QC3 | BECKMAN COULTER, INC. |
30 | 15099590210700 | B11056 | B11056 | The Access sTfR QC1 is intended for monitoring system performance of the Access The Access sTfR QC1 is intended for monitoring system performance of the Access sTfR assay. | Access sTfR QC1 | BECKMAN COULTER, INC. |
31 | 15099590204051 | A48619 | A48619 | The Access SHBG QC is intended for monitoring system performance of the Access SHBG assay. | Access SHBG QC | BECKMAN COULTER, INC. |
32 | 15099590203061 | A36100 | A36100 | The Access Inhibin A QC is intended for monitoring system performance of the Acc The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay. | Access Inhibin A QC | BECKMAN COULTER, INC. |
33 | 14987666543023 | B96698 | AU5800 Chemistry Analyzer, Automation-ready | AU | BECKMAN COULTER, INC. | |
34 | 14987666543016 | B96697 | AU5800 Chemistry Analyzer | AU | BECKMAN COULTER, INC. | |
35 | 14987666543009 | B96696 | AU680 Chemistry Analyzer (with ISE) | AU | BECKMAN COULTER, INC. | |
36 | 14987666542996 | B96695 | AU680 Chemistry Analyzer for Direct Track Sampling (with ISE) | AU | BECKMAN COULTER, INC. | |
37 | 14987666542989 | B96694 | AU680 Chemistry Analyzer | AU | BECKMAN COULTER, INC. | |
38 | 14987666542972 | B96693 | AU480 Chemistry Analyzer (with ISE) | AU | BECKMAN COULTER, INC. | |
39 | 14987666542965 | B96692 | AU480 Chemistry Analyzer | AU | BECKMAN COULTER, INC. | |
40 | 14987666542545 | B86444 | DxC 700 AU Chemistry Analyzer (with ISE) | DxC AU | BECKMAN COULTER, INC. | |
41 | 14987666542514 | B86446 | DxC 700 AU, Direct Track Sampling (with ISE) | DxC AU | BECKMAN COULTER, INC. | |
42 | 14987666542507 | B86445 | DxC 700 AU Chemistry Analyzer, Direct Track Sampling | DxC AU | BECKMAN COULTER, INC. | |
43 | 14987666542491 | B86443 | DxC 700 AU Chemistry Analyzer | DxC AU | BECKMAN COULTER, INC. | |
44 | 14987481164571 | 997-00201 | 997-00201 | In-Vitro Diagnostic Use | L-Type HDL-C Reagent 2 | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
45 | 14987481164564 | 991-00101 | 991-00101 | In-Vitro Diagnostic Use | L-Type HDL-C Reagent 1 | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
46 | 14987481164557 | 990-28011 | 990-28011 | In-Vitro Diagnostic Use | HDL-C/LDL-C Calibrator | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
47 | 14987481164496 | 991-61401 | 991-61401 | In-Vitro Diagnostic Use | uTASWako DCP Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
48 | 14987481164489 | 995-61301 | 995-61301 | In-Vitro Diagnostic Use | uTASWako DCP Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
49 | 14987481164458 | 993-61101 | 993-61101 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control H | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
50 | 14987481164441 | 997-61001 | 997-61001 | In-Vitro Diagnostic Use | uTASWako AFP-L3 Control L | FUJIFILM WAKO PURE CHEMICAL CORPORATION |