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 | 05051700019057 | NQ043.L.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Beta-2 Microglobulin Urine Control Pack | ||
45 | 05051700018951 | NQ058.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Haptoglobin Control Pack | ||
46 | 05051700018920 | NQ007.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® IgG2 Control Pack | ||
47 | 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® | ||
48 | 05051700018760 | NQ016.OPT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Optilite® Freelite® Kappa Free Control Pack | ||
49 | 05051700018494 | NK624.OPT.A | OPY | Igal Heavy & Light Chain Combined | 2 | Optilite Hevylite® IgA Lambda Kit | ||
50 | 05051700018456 | NK044.S.A | DCN | System, Test, C-Reactive Protein | 2 | C-Reactive Protein Kit for SPAPLUS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00856176008032 | 00856176008032 | 00856176008032 | Level 2 Control Solution (150 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
2 | 00856176008025 | 00856176008025 | 00856176008025 | Level 1 Control Solution (75 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
3 | 00855574005391 | HCG-POCU | Qualitative HCG Control, Urine | Poly stat | POLYMEDCO, INC. | |
4 | 00855574005377 | HCG-POC | Qualitative HCG Control | Poly stat | POLYMEDCO, INC. | |
5 | 00854427007148 | KIT - Glucose Monitoring System | Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lan Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual | HEPRO.US MM1000 Blood Glucose Monitoring System Kit | HEPRO.US INC. | |
6 | 00854067005238 | EHS-SDMK-V | Smart Diabetes Voice Glucose Monitor | Smart Diabetes | VALUE PROVIDERS LLC | |
7 | 00854067005191 | EHS-SDMK-BT | Smart Diabetes Bluetooth Glucose Monitor | Eocene | VALUE PROVIDERS LLC | |
8 | 00853553005257 | Livongo G1.5 | KIT00441 | Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of L Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Welcome Kit | LIVONGO HEALTH, INC |
9 | 00853553005202 | Livongo | OFG00426 | Livongo Control Solution with 1 bottle high / 1 bottle low | Livongo Control Solution | LIVONGO HEALTH, INC |
10 | 00853553005158 | In Touch | OFG00155 | In Touch Control solution with 1 bottle high, 1 bottle low | In Touch Glucose Control Solution | LIVONGO HEALTH, INC |
11 | 00853553005103 | In Touch | KIT00147 | 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch hi 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution | In Touch Refill Kit | LIVONGO HEALTH, INC |
12 | 00853553005028 | In Touch | OFG00140 | Box of High/Low Control Solution | In Touch Glucose Control Solutions | LIVONGO HEALTH, INC |
13 | 00853483008199 | VGC01 | VGC01-372 | VivaGuard Ino Control Solution (1 & 3) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
14 | 00853483008175 | VGC01 | VGC01-373 | VivaGuard Ino Control Solution 2 (1 bottle/kit) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
15 | 00853483008076 | VGC01 | VGC01-371 | VivaGuard Ino Control Solution (L, M, H, 1 bottle/each) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
16 | 00852668007187 | BLE-CS3 | Control Solution Box 3 Pack | BLE Smart® Control Solution | ENTRA HEALTH SYSTEMS LLC | |
17 | 00850578007396 | CT Glucosemeter kits | Case/Carton of 40 boxes of ONE GLUCOSEMETER KIT HEPRO.US MM1000 Copy | HEPRO.US MM1000 BRAND CT40 GLUCOSEMETER KIT - | HEPRO.US INC. | |
18 | 00850229007195 | 405 | E002-405 | Analyzer Quality Control | DriDye 405 | AWARENESS TECHNOLOGY, INCORPORATED |
19 | 00850229007188 | 405/ 450 | Analyzer Quality Control | DriDye 405/ 450 | AWARENESS TECHNOLOGY, INCORPORATED | |
20 | 00850229007171 | 450 | E002-450 | Analyzer Quality Control | DriDye 450 | AWARENESS TECHNOLOGY, INCORPORATED |
21 | 00850229007164 | 492 | E002-492 | Analyzer Quality Control | DriDye 492 | AWARENESS TECHNOLOGY, INCORPORATED |
22 | 00850212007089 | 2130166 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
23 | 00850212007034 | 2130152 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
24 | 00850081003212 | MGH-CS3 | Control Solution 3 Pak | MyGlucoHealth® Control Solution 3-Pack | ENTRA HEALTH SYSTEMS LLC | |
25 | 00850065006215 | 1054-05 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
26 | 00850065006048 | 1054-01 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
27 | 00850017460058 | S5800382 | S5800382 | Level 1 & 2 | BIOCOACH Glucose Control Solution L1/L2 | AMVENTUREX, INC. |
28 | 00850011135495 | 801mm | aHBs Calibration Verification / Linearity Test kit | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
29 | 00850011135457 | 506ro | Validate VIT D Single clinical chemistry analyte IVD, control | VALIDATE | LGC CLINICAL DIAGNOSTICS, INC. | |
30 | 00850011135402 | 510mm | Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
31 | 00850011135372 | 908bc | Validate THY2 IVD Control | Validate | LGC CLINICAL DIAGNOSTICS, INC. | |
32 | 00850011135327 | 605sa | 605sa | Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
33 | 00850011135310 | 509ro | 509ro | Validate IL-6 is intended for the quantitative determination of Calibration Veri Validate IL-6 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
34 | 00850011135280 | 405ab | 405ab | Validate High Sensitive Troponin I is intended for the quantitative determinatio Validate High Sensitive Troponin I is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
35 | 00850011135259 | 303ro | 303ro | Validate PTH is intended for the quantitative determination of Calibration Verif Validate PTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
36 | 00850011135211 | 302mm | 302mm | Validate ACTH is intended for the quantitative determination of Calibration Veri Validate ACTH is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
37 | 00850006113064 | Curo L5 | CURO L5 Glucose Strip | Curo L5 | KPI HEALTHCARE, INC. | |
38 | 00850004812242 | 702013 | 702013 | Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Contr Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Control, 5mL Kitbox | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
39 | 00850001462419 | v1 | GOJJI KETONE CONTROL SOLUTION-L1 | GOJJI, INC. | ||
40 | 00850001462402 | v1 | GOJJI GLUCOSE CONTROL SOLN-NORMAL | GOJJI, INC. | ||
41 | 00847865011648 | 6633740 | 6633740 | 25-OH Vitamin D Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
42 | 00847865011631 | 6633730 | 6633730 | 25-OH Vitamin D Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
43 | 00847865010894 | 6632240 | 6632240 | Celiac IgG Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
44 | 00847865010887 | 6632340 | 6632340 | Celiac IgA Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
45 | 00847865010627 | 6632230 | 6632230 | Celiac IgG Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
46 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
47 | 00847865001168 | 6633840 | 6633840 | Rubella & CMV IgM Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
48 | 00847865001151 | 6633830 | 6633830 | Rubella & CMV Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
49 | 00847865000703 | 6632140 | 6632140 | APLS IgA Control Lot Data | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00847865000697 | 6632130 | 6632130 | APLS IgA Control Set | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |