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 | 00380740193720 | 06S6001 | 06S6001 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | QKO | Reagent, coronavirus serological | ARCHITECT | |
31 | 00380740192167 | 06R8730 | 06R8730 | AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test | QKO | Reagent, coronavirus serological | ARCHITECT | |
32 | 00380740192099 | 06R9130 | 06R9130 | AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test | QKO | Reagent, coronavirus serological | Alinity | |
33 | 00380740192082 | 06R9120 | 06R9120 | AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test | QKO | Reagent, coronavirus serological | Alinity | |
34 | 00380740192075 | 06R9110 | 06R9110 | AdviseDx SARS-CoV-2 IgM Control Kit | QKO | Reagent, coronavirus serological | Alinity | |
35 | 00380740192068 | 06R9101 | 06R9101 | AdviseDx SARS-CoV-2 IgM Calibrator 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 | 00812277030068 | 2762-32702 | 2762-32702 | Curaplex Control Solution 2/BT | Curaplex | BOUND TREE MEDICAL, LLC |
2 | 00811727015594 | L7597-CTL | L7597-CTL | Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitorin Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For in vitro diagnostic use. | Pointe Lipoprotein (a) Control Set | POINTE SCIENTIFIC, INC. |
3 | 00810042683181 | 702012 | 702012 | HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
4 | 00810042683174 | 18003155 | hCG Low Positive/Negative Urine 2x5mL Kitbox | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
5 | 00810042683129 | 2110005 | 18000347 | CenMed hCG URINE Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
6 | 00810042683112 | 2110007 | 18000346 | CenMed hCG URINE Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
7 | 00810042682962 | 2122015 | 18000698 | CenMed hCG Serum Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
8 | 00810042682948 | 2122017 | 18000697 | CenMed hCG Serum Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
9 | 00810042682900 | Custom QC31 | PREGNANCY SKREEN Custom hCG Serum 4mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
10 | 00810042682894 | Custom QC30 | PREGNANCY SKREEN Custom hCG Serum 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
11 | 00810042681415 | Custom QC25 | PREGNANCY SKREEN Custom hCG Liquid Urine 50mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
12 | 00810042681408 | Custom QC24 | PREGNANCY SKREEN Custom hCG Liquid Urine 20mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
13 | 00810042681392 | Custom QC23 | PREGNANCY SKREEN Custom hCG Liquid Urine 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
14 | 00810042681385 | Custom QC22 | PREGNANCY SKREEN Custom hCG Liquid Urine 2mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
15 | 00810042681347 | Custom QC18 | PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
16 | 00810042681156 | 18030367 | 18030367 | HCG Urine 2x4mL dropper Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
17 | 00810042681095 | 18000656 | 18000656 | CONSULT HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
18 | 00810042681088 | 18000443 | 18000443 | Cardinal HCG 4mL Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
19 | 00810042681071 | 18000442 | 18000442 | ALERE HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
20 | 00804084000150 | GCS0104 | For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of b For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips. | IDEAL LIFE Control Solution Level II | IDEAL LIFE INC | |
21 | 00804084000143 | AGS-1112 | IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) | IDEAL LIFE INC | ||
22 | 00793150629794 | IGM-1003A | INFCN003L | Glucose Control Solution | Oh’Care Lite Glucose Control Solution | OSANG HEALTHCARE CO., LTD. |
23 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | Oh’Care Lite Blood Glucose Monitoring System Kit | OSANG HEALTHCARE CO., LTD. | |
24 | 00763924540105 | MD540 | Lipid and Glucose Measuring System | LipidPlus® Glucose Test Strips | JANT PHARMACAL CORPORATION | |
25 | 00748349000717 | 10001 | 10001 | Glucose Pilot - The Complete Glucose Monitoring System | Glucose Pilot | SYNTRON BIORESEARCH, INC. |
26 | 00742860100178 | 176 | 176 | OSOM H. Pylori Control Kit | SEKISUI DIAGNOSTICS, LLC | |
27 | 00742860100093 | 138 | 138 | HCG SERUM CONTROL KIT | SEKISUI DIAGNOSTICS, LLC | |
28 | 00732671109422 | 942-2 | 942-2 | Control Solution - L2 (High) | Pip | AMITY HOLDINGS, LLC |
29 | 00732671009425 | 942-1 | 942-1 | Control Solution - L1 (low) | Pip | AMITY HOLDINGS, LLC |
30 | 00732671009401 | 940 | 940 | Blood Glucose Test Meter | Pip | AMITY HOLDINGS, LLC |
31 | 00699073704320 | 70432 | 70432 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
32 | 00699073140029 | 14002 | 14002 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
33 | 00695684781026 | 78102 | AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStri AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStrip® HB Hemoglobin (Hb) Meter. | AIMSTRIP HEMOGLOBIN OPTICAL VERIFIERS | GERMAINE LABORATORIES, INC | |
34 | 00695684775124 | ILM-0001A | blood glucose meter and test strip control solution-level 1,2,3 | AimStrip Tandem Glucose control solution | OSANG HEALTHCARE CO., LTD. | |
35 | 00695684774127 | ILM-0001A | Lipid measuring meter and Triglycerides test strip control solution level 1,2 | AimStrip Tandem Total Triglycerides Control Solution | OSANG HEALTHCARE CO., LTD. | |
36 | 00695684773120 | ILM-0001A | Lipid measuring meter and Total Cholesterol test strip control solution level 1,2 | AimStrip Tandem Total Cholesterol Control Solution | OSANG HEALTHCARE CO., LTD. | |
37 | 00695684773014 | ILM-0001A | Lipid and Glucose Measuring System | AimStrip Tandem Lipid Profile and glucose measuring system | OSANG HEALTHCARE CO., LTD. | |
38 | 00695684373122 | 37312 | Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test St Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test Strips & meter for testing blood glucose levels | AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION | GERMAINE LABORATORIES, INC | |
39 | 00695684131128 | 13112 | Ketone controls for use with ketone tests, 1 Positive and 1 Negative | KETONE SERUM CONTROLS | GERMAINE LABORATORIES, INC | |
40 | 00682607571017 | G117-108 | 757101 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Voice Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
41 | 00682607558315 | G125-12L | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Pro Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
42 | 00682607558117 | G115-107 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Pal Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
43 | 00682607557325 | G125-12D | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Express Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
44 | 00682607557158 | G115-10D | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
45 | 00682607556311 | G125-122 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Vivid Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
46 | 00682607556113 | G115-102 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
47 | 00682607550128 | G115-10S | 755012 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Mobile Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
48 | 00682607535316 | G123-311 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Plus Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
49 | 00682607535118 | G113-111 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Plus Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
50 | 00682607200023 | C122-3041 | 2mL bottles of Level 0, Level 1, Level 2 | Mission Plus Hemoglobin (Hb) Control Solution Kit | ACON LABORATORIES, INC. |