No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00695684775506 | ILM-0001A | AimStrip Tandem blood glucose test strips | CGA | Glucose Oxidase, Glucose | 2 | AimStrip Tandem blood glucose test strips | |
2 | 00695684773120 | ILM-0001A | Lipid measuring meter and Total Cholesterol test strip control solution level 1,2 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AimStrip Tandem Total Cholesterol Control Solution | |
3 | 00695684773014 | ILM-0001A | Lipid and Glucose Measuring System | CGA,JJX,CHH,JGY | Glucose Oxidase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassa Glucose Oxidase, Glucose,Single (Specified) Analyte Controls (Assayed And Unassayed),Enzymatic Esterase--Oxidase, Cholesterol,Colorimetric Method, Triglycerides | 1 | AimStrip Tandem Lipid Profile and glucose measuring system | |
4 | 08809115905802 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'care Lite Smart Glucose Meter | ||
5 | 08809115904645 | OI-01SA-SH | FBE00625 | 1 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
6 | 08809115904621 | OI-01SA-SH | FBE00608 | 2 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
7 | 08809115904614 | OI-01SA-SH | FBE00626 | 4 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
8 | 08809115904607 | OI-01SA-SH | FBE00627 | 5 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
9 | 08809115904591 | OI-01SA-SH | FBE00641 | 25 Test Kit / Box | OHC COVID-19 Antigen Self Test | |||
10 | 00793150629794 | IGM-1003A | INFCN003L | Glucose Control Solution | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Oh’Care Lite Glucose Control Solution |
11 | 00793150629770 | IGM-1003A | INFM003L | Blood Glucose Monitoring System for Self-Testing | NBW,LFR | System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | 2 | Oh’Care Lite Blood Glucose Monitoring System for Self-Testing |
12 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | JJX,NBW,LFR | Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | 1 | Oh’Care Lite Blood Glucose Monitoring System Kit | |
13 | 00695684774103 | ILM-0001A | Triglycerides test strip | JGY | Colorimetric Method, Triglycerides | 1 | AimStrip Tandem Total Triglycerides Test Strips | |
14 | 08809115905697 | IGM-1003A | Blood Glucose Test strips Refill kit | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip Refill kit | |
15 | 00695684773106 | ILM-0001A | Total Cholestesol test strip | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | AimStrip Tandem Total Cholesterol Test Strips | |
16 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | JJX,NBW,CGA | Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Single (Specified) Analyte Controls (Assayed And Unassayed),System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Element™ Meter | ||
17 | 08809115906540 | IGM-1003F | blood glucose test strip | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'Care Lite Smart Glucose Test Strip | |
18 | 08809115905406 | ILM-0001A | CHH,JGY | Enzymatic Esterase--Oxidase, Cholesterol,Colorimetric Method, Triglycerides | 1 | CURO L5 Meter | ||
19 | 00793150629787 | IGM-1003A | INFS003L | Blood Glucose Test strips | NBW,LFR | System, Test, Blood Glucose, Over The Counter,Glucose Dehydrogenase, Glucose | 2 | Oh’Care Lite Blood Glucose Test strips |
20 | 08809115908957 | IGM-0021B | Blood Glucose Monitoring System | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Element™Plus Test Strips | ||
21 | 08809115908438 | IGM-0021B | Blood Glucose Monitoring System | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Element™ Test Strips | ||
22 | 08809115905710 | IGM-1003A | Blood Glucose Test strips | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip | |
23 | 08809115905444 | ILM-0001A | JGY | Colorimetric Method, Triglycerides | 1 | CURO L5 TG test strip | ||
24 | 00695684775124 | ILM-0001A | blood glucose meter and test strip control solution-level 1,2,3 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AimStrip Tandem Glucose control solution | |
25 | 08809115905413 | ILM-0001A | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | CURO L5 TC test strip | ||
26 | 08809115905369 | IGM-1003A | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose Test Strip(25T) | ||
27 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | CGA,NBW,JJX | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter,Single (S Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter,Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Element™Plus Meter | |
28 | 08809115905796 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'care Lite Smart Glucose Test Strip | ||
29 | 08809115905727 | IGM-1003A | blood glucose monitoring system for self-testing meter | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose meter | |
30 | 08809115905703 | IGM-1003A | blood glucose monitoring system for self-testing starter kit | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Glucose monitoring system starter kit | |
31 | 08809115905376 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Pro Glucose meter | ||
32 | 08809115904263 | OI-01SA-SH | FBE00656 | 1 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
33 | 08809115904256 | OI-01SA-SH | FBE00657 | 2 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
34 | 08809115904249 | OI-01SA-SH | FBE00658 | 4 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
35 | 08809115904232 | OI-01SA-SH | FBE00659 | 5 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
36 | 08809115904225 | OI-01SA-SH | FBE00660 | 25 Test Kit / Box | QuickFinder COVID-19 Antigen Self Test | |||
37 | 08809115905352 | IGM-1003F | NBW | System, Test, Blood Glucose, Over The Counter | 2 | OKRA Pro Glucose monitoring system starter kit | ||
38 | 00695684774127 | ILM-0001A | Lipid measuring meter and Triglycerides test strip control solution level 1,2 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AimStrip Tandem Total Triglycerides Control Solution | |
39 | 08809115906557 | IGM-1003F | blood glucose monitoring system for self-testing | NBW | System, Test, Blood Glucose, Over The Counter | 2 | Oh'Care Lite Smart Glucose monitoring system | |
40 | 08809115906526 | IGM-1003F | blood glucose meter and test strip control solution-Level 2 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Oh'Care Lite Smart Glucose control solution-Level 2 | |
41 | 08809115904119 | ILM-0001A | INFSG001EF | Glucose test strip(25T) | NBW | System, Test, Blood Glucose, Over The Counter | 2 | CURO L5 Glucose test strip |
42 | 08809115906533 | IGM-1003F | blood glucose meter and test strip control solution-level 3 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Oh'Care Lite Smart Glucose control solution-Level 3 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07070060014722 | 1116792 | 1116792 | HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert. | Afinion HbA1c Calibration Verification | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
2 | 07070060014661 | 1116975 | 1116975 | HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 C HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 Control C II, 1 package insert. | Afinion HbA1c Control | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
3 | 07070060006505 | 1115178 | 1115178 | HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 Control C1. 1 Control C II. 1 package insert. DI covers Alere Afinion HbA1c Control and Afinion HbA1c Control. | Alere Afinion HbA1c Control | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
4 | 06438115000112 | 145217 | 145217 | QuikRead go® CRP Control Set is intended for use as assayed quality-control mate QuikRead go® CRP Control Set is intended for use as assayed quality-control material for monitoring the performance of the quantitative QuikRead go CRP assay with the QuikRead go Instrument. | QuikRead go® CRP Control set | AIDIAN OY |
5 | 06438115000105 | 145216 | 145216 | QuikRead go® CRP Verification Set is designed to be used for calibration verific QuikRead go® CRP Verification Set is designed to be used for calibration verification and for method validation of the QuikRead go® CRP system. It is intended for use with the QuikRead go® CRP test and the QuikRead go® instrument. | QuikRead go® CRP Verification set | AIDIAN OY |
6 | 05700572014294 | X0974 | Cystatin C Calibrator | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
7 | 05700572014287 | X0973 | Cystatin C Control Set | Cystatin C Control Set | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
8 | 05700572013853 | LX002 | Cystatin C Immunoparticles | Dako | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | |
9 | 05415168004763 | 08240426190 | 08240426190 | Assayed control for Alpha2-Macroglobulin assay on cobas c501/502 systems. | Alpha2-Macroglobulin Serum CONT KIT | DIAGAM |
10 | 05391516748216 | Tri-stat Liquid Controls Kit | 03-06-0011 | Hemoglobin A1c assay, Tri-stat Liquid Controls Kit | Trinity Biotech | PRIMUS CORPORATION |
11 | 05391516747240 | A7040 | A7040 | ACE CONTROL-E | Trinity Biotech | CLARK LABORATORIES, INC. |
12 | 05391516747233 | A6040 | A6040 | ACE CONTROL-N | Trinity Biotech | CLARK LABORATORIES, INC. |
13 | 05391516741897 | 450-22 | 450-22 | Bile Acids Controls | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
14 | 05060169695979 | IS-ID6530 | IDS SARS-COV-2 IgG Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
15 | 05060169695825 | IS-2835US | IDS-iSYS Ostase® BAP Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
16 | 05060169695818 | IS-2830US | IDS-iSYS Ostase® BAP Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
17 | 05060169695504 | IS-4620 | IDS Cortisol Calibrator Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
18 | 05060169695306 | IS-2530 | IDS-iSYS 25 VitDS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
19 | 05060169693708 | IS-5635 | IDS SHBG Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
20 | 05060169691339 | IS-5630 | IDS SHBG Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
21 | 05060169691070 | IS-5135 | IDS-iSYS 17-OH Progesterone Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
22 | 05060169691049 | IS-4835 | IDS-iSYS Direct Renin Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
23 | 05060169691001 | IS-4435 | IDS-iSYS Insulin like Growth Factor Binding Protein-3 (IGFBP-3) Cal Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
24 | 05060169690981 | IS-3935 | IDS-iSYS Insulin like Growth Factor-I (IGF-1) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
25 | 05060169690974 | IS-3735 | IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
26 | 05060169690967 | IS-3335 | IDS-iSYS Aldosterone Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
27 | 05060169690950 | IS-3235 | IDS-iSYS Intact PTH Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
28 | 05060169690943 | IS-3035 | IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
29 | 05060169690929 | IS-2535 | IDS-iSYS 25 VitDS Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
30 | 05060169690912 | IS-2435 | IDS-iSYS 1,25-Dihydroxy Vitamin D Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
31 | 05060169690882 | IS-5130 | IDS-iSYS 17-OH Progesterone Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
32 | 05060169690851 | IS-4830 | IDS-iSYS Direct Renin Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
33 | 05060169690820 | IS-4630 | IDS Cortisol Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
34 | 05060169690752 | IS-2530 | IDS-iSYS 25 VitDS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
35 | 05060169690424 | IS-2735S | IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
36 | 05060169690417 | IS-2730S | IDS-iSYS 25-Hydroxy Vitamin DS Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
37 | 05060169690370 | IS-3330 | IDS-iSYS Aldosterone Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
38 | 05060169690356 | IS-2430 | IDS-iSYS 1,25-Dihydroxy Vitamin D Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
39 | 05060169690318 | IS-4430 | IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
40 | 05060169690295 | IS-3930 | IDS-iSYS Insulin like Growth Factor-1 (IGF-I) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
41 | 05060169690271 | IS-3230 | IDS-iSYS Intact PTH Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
42 | 05060169690257 | IS-3030 | IDS-iSYS CTX-I (Crosslaps) Control Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
43 | 05055845400022 | FHCY200 | FHCY200 | The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed qu The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma. | Axis-Shield Homocysteine Controls | AXIS-SHIELD DIAGNOSTICS LIMITED |
44 | 05055845400015 | FHCY100 | FHCY100 | The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. | Axis® Homocysteine EIA | AXIS-SHIELD DIAGNOSTICS LIMITED |
45 | 05055273217797 | AMH10515 | AMH10515 | The AMH Control Level 3 (AMH10515) is intended for use with in vitro diagnostic The AMH Control Level 3 (AMH10515) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 3 (AMH10515) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 3 (AMH10515) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | AMH CONTROL LEVEL 3 (AMH CONTROL 3) | RANDOX LABORATORIES LIMITED |
46 | 05055273217780 | AMH10514 | AMH10514 | The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 2 (AMH10514) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 2 (AMH10514) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | AMH CONTROL LEVEL 2 (AMH CONTROL 2) | RANDOX LABORATORIES LIMITED |
47 | 05055273217773 | AMH10509 | AMH10509 | The AMH Control Level 1 (AMH10509) is intended for use with in vitro diagnostic The AMH Control Level 1 (AMH10509) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 1 (AMH10509) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 1 (AMH10509) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | AMH CONTROL LEVEL 1 (AMH CONTROL 1) | RANDOX LABORATORIES LIMITED |
48 | 05055273217766 | AMH10516 | AMH10516 | The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers.The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | AMH CONTROL LEVEL 4 (AMH CONTROL 4) | RANDOX LABORATORIES LIMITED |
49 | 05055273217346 | CQ10428 | CQ10428 | This product is intended for intended for use with in vitro diagnostic assays, f This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation. | CARDIAC ULTRA LOW CONTROL (CRD CONTROL Ultra Low) | RANDOX LABORATORIES LIMITED |
50 | 05055273216936 | COV10460 | COV10460 | "SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Negative/Non-Reactiv "SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Negative/Non-Reactive ControlSARS-CoV-2 Negative/Non-Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus).SARS-CoV-2 Negative/Non-Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems.SARS-CoV-2 (Severe acute respiratory syndrome coronavirus) Positive/Reactive ControlSARS-CoV-2 Positive/Reactive Control is intended for use with in vitro assays for determination of Total antibodies to SARS-CoV-2 (Severe acute respiratory syndrome coronavirus).SARS-CoV-2 Positive/Reactive Control is unassayed without target values and is suitable for use on various analysers. SARS-CoV-2 Negative/Non-Reactive Control is useful in determining the precision of testing systems and allows performance monitoring of multiple test systems." | SARS CoV-2 Controls (SARS-CoV-2) | RANDOX LABORATORIES LIMITED |