No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 05051700020381 | NC022.A | JIS | Calibrator, Primary | 2 | Complement C2 Calibrator Set | ||
2 | 05051700020374 | NB136 | PPM | General Purpose Reagent | 1 | General Purpose Reaction Buffer | ||
3 | 05051700020367 | LK022.A | MVU | Reagents, Specific, Analyte | 1 | Anti-Human Complement C2 Latex Reagent | ||
4 | 05051700020336 | MA012 | MVU | Reagents,Specific,Analyte | 1 | Anti-Human IgM - Particle - ASR pack | ||
5 | 05051700020152 | LK044.L.OPT.A | DCN | System, Test, C-Reactive Protein | 2 | Optilite High Sensitivity C-Reactive Protein Kit | ||
6 | 05051700019378 | NK621.S.A | PCN | Immunoglobulin G Kappa Heavy And Light Chain Combined | 2 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS | ||
7 | 05051700019118 | NQ012.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® IgM Control Pack | ||
8 | 05051700019071 | NQ032.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Albumin Control Pack | ||
9 | 05051700019064 | NQ043.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Beta-2 Microglobulin Control Pack | ||
10 | 05051700018975 | NQ189.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Anti-streptolysin O Control Pack | ||
11 | 05051700018722 | NQ016.S | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Freelite® Human Kappa Free Control Pack for use on the SPAPLUS® | ||
12 | 05051700018616 | NQ013.T | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Human IgD Control Pack for use on the Siemens BN™II | ||
13 | 05051700017978 | LK009.10S.A | CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | Human IgG4 SPA PLUS Bulk Kit | ||
14 | 05051700017916 | NK032.OPT.A | DCF | Albumin, Antigen, Antiserum, Control | 2 | Optilite Albumin Kit | ||
15 | 05051700017534 | NK004.OPT.A | CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | Optilite IgG Kit | ||
16 | 05051700016926 | NK624.T.A | CFN,OPY | Method, Nephelometric, Immunoglobulins (G, A, M),Igal Heavy & Light Chain Combined | 2 | Hevylite IgA Lambda Kit for Siemens BNII | ||
17 | 05051700016742 | NK010.10S | CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | Human IgA kit for use on SPAPLUS- Bulk Kit | ||
18 | 05051700016469 | NK039.S | DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 2 | Human alpha 2 macroglobulin Kit for use on SPAPLUS | ||
19 | 05051700016407 | LK009.10S | Human IgG4 Subclass Liquid Reagent Kit for use on the SPAPLUS- Bulk Kit | |||||
20 | 05051700016346 | NK045.S | DDB | Ceruloplasmin, Antigen, Antiserum, Control | 2 | Human Caeruloplasmin Kit for use on SPAPLUS | ||
21 | 05051700016193 | NK032.L.S | DCF | Albumin, Antigen, Antiserum, Control | 2 | Human Albumin CSF Kit for use on SPAPLUS | ||
22 | 05051700016186 | NK004.L.S | CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | Human IgG CSF Kit for use on SPAPLUS | ||
23 | 05051700016100 | NK066.S | JZJ | Prealbumin, Antigen, Antiserum, Control | 1 | Human Prealbumin Kit for use on SPAPLUS | ||
24 | 05051700012461 | NK622.T | Hevylite® Human IgG Lambda Kit for use on the Siemens BN™II | |||||
25 | 05051700011372 | ZK032.U.R | MININEPH™ Human Microalbumin Kit | |||||
26 | 05051700011327 | ZK012.R | MININEPH™ Human IgM Kit | |||||
27 | 05051700011273 | ZK006.R | MININEPH Human IgG1 Kit | |||||
28 | 05051700010917 | RN106.3 | DEW | Igg, Antigen, Antiserum, Control | 2 | Human IgG1 Subclass Single Dilution BINDARID™ Kits | ||
29 | 05051700010764 | RN065.3 | DDX | Plasminogen, Antigen, Antiserum, Control | 1 | Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion Kit | ||
30 | 05051700010283 | RC001.3 | DAE | Complement C9, Antigen, Antiserum, Control | 2 | Total Haemolytic Complement | ||
31 | 05051700010276 | RC001.2 | DAE | Complement C9, Antigen, Antiserum, Control | 2 | Total Haemolytic Complement | ||
32 | 05051700010269 | RC001.1 | DAE | Complement C9, Antigen, Antiserum, Control | 2 | Total Haemolytic Complement | ||
33 | 05051700007702 | NK007.IM | CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | Human IgG2 Subclass Liquid Reagent Kit for use on the Beckman IMMAGE®/IMMAGE®800 | ||
34 | 05051700006446 | LK018.IM | DEH | Lambda, Antigen, Antiserum, Control | 2 | Freelite® Human Lambda Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®80 | ||
35 | 05051700006408 | LK018.AU | DEH | Lambda, Antigen, Antiserum, Control | 2 | Freelite® Human Lambda Free Kit for use on the Beckman AU® series | ||
36 | 05051700006286 | LK016.AU | DEH | Lambda, Antigen, Antiserum, Control | 2 | Freelite® Human Kappa Free Kit for use on the Beckman AU® series | ||
37 | 05051700006255 | LK013.T | CZJ | Igd, Antigen, Antiserum, Control | 2 | Human IgD Liquid Latex Reagent Kit for use on the Siemens BN™II | ||
38 | 05051700020909 | IK702 | JRI | Cuvette, Thermostated | 1 | Tencell™ cuvettes | ||
39 | 05051700020343 | MA015 | MVU | Reagents,Specific,Analyte | 1 | Anti-Human Total Kappa - Particle - ASR pack | ||
40 | 05051700020190 | LK010.L.OPT.A | CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | Optilite IgA CSF Kit | ||
41 | 05051700020084 | NC044.OPT.A | DCN | System, Test, C-Reactive Protein | 2 | Optilite C-Reactive Protein Calibrator | ||
42 | 05051700019439 | NQ624.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Hevylite Iga Lambda Control Pack | ||
43 | 05051700019422 | NQ623.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Hevylite® IgA Kappa Control Pack | ||
44 | 05051700018951 | NQ058.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Haptoglobin Control Pack | ||
45 | 05051700018920 | NQ007.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® IgG2 Control Pack | ||
46 | 05051700018784 | NQ016.RI | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Freelite® Human Kappa Free Control Pack For use on the Roche Cobas Integra® | ||
47 | 05051700018760 | NQ016.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Freelite® Kappa Free Control Pack | ||
48 | 05051700018494 | NK624.OPT.A | OPY | Igal Heavy & Light Chain Combined | 2 | Optilite Hevylite® IgA Lambda Kit | ||
49 | 05051700018456 | NK044.S.A | DCN | System, Test, C-Reactive Protein | 2 | C-Reactive Protein Kit for SPAPLUS | ||
50 | 05051700018289 | NK626.S.A | Immunoglobulin M Lambda Heavy And Light Chain Combined | 2 | Hevylite® Human IgM Lambda Kit for use on the SPAPLUS |
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 |