No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00847865000758 | 6632440 | 6632440 | MMRV IgG Control Lot Data | OPL,LJY,LFY,LJB | Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zost Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
2 | 00847865000437 | 6631640 | 6631640 | ToRC IgG Control Lot Data | JJY | Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
3 | 00847865013017 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
4 | 00847865013000 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
5 | 00847865012997 | SW4.1_1 | 6652165B | Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
6 | 00847865012980 | SW4.1V1 | 6652065B | Manual & CDs, APLS IgM IFU, SW4.1_v1 | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
7 | 00847865012973 | SW4.1V1 | 6651975B | APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
8 | 00847865012966 | SW4.1V1 | 6651965B | Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
9 | 00847865012614 | SW4.1_V1 | 6651260F | Manual & CDs, EBV IgG IFU, SW4.1v1 | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
10 | 00847865012607 | SW4.1_V1 | 6651270D | EBV IgG Assay Protocol File CD, SW4.1_v1, US | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
11 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
12 | 00847865012522 | SW4_1 | 6651965A | Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
13 | 00847865012515 | SW4_1 | 6652065A | Manual & CDs, APLS IgM IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
14 | 00847865012508 | SW4_1 | 6651975A | APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
15 | 00847865012331 | SW4.1_V2 | 6651170D | ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 | LLL,LKJ,LJM,MQA,LKO,LRM | EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTI EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL,ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS,ANTI-RIBOSOMAL P ANTIBODIES,ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL,ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL | 2 | BioPlex 2200 |
16 | 00847865011655 | 6653750 | 6653750 | 25-OH Vitamin D Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | BioPlex 2200 |
17 | 00847865011648 | 6633740 | 6633740 | 25-OH Vitamin D Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
18 | 00847865011631 | 6633730 | 6633730 | 25-OH Vitamin D Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
19 | 00847865011624 | 6633720 | 6633720 | 25-OH Vitamin D Lot Data | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
20 | 00847865011617 | 6633700 | 6633700 | 25-OH Vitamin D Calibrator Set | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
21 | 00847865011358 | SW4V2 | 6651360F | Manual & CDs, EBV IgM IFU, SW4_v2 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
22 | 00847865011341 | 6651360G | 6651360G | Manual & CDs, EBV IgM IFU, SW4.1_v1 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
23 | 00847865011129 | SW4_1 | 6652360A | Manual & CDs, Celiac IgA and IgG IFU, SW4_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
24 | 00847865011105 | 6600306 | 6600306 | BioPlex® 2200 Manual Reagent Pack Piercer | MZF | Test, Hiv Detection | 2 | BioPlex® 2200 |
25 | 00847865011082 | SW4.1V1 | 6651860H | Manual & CDs, Vasculitis IFU, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
26 | 00847865011075 | SW4.1_1 | 6651665E | U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
27 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
28 | 00847865010993 | SW4.1_V2 | 6653370E | HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2 | MYF,MXJ | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 | 2 | BioPlex 2200 |
29 | 00847865010986 | SW4.1_V1 | 6653270E | BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1 | JIX,NHX,JJY | CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP),Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
30 | 00847865010979 | SW4.1_V1 | 6652470D | MMRV IgG Assay Protocol File CD, SW4.1_v1 | LJY,LFY,OPL,LJB | ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT A ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
31 | 00847865010962 | SW4.1v1 | 6652270B | Celiac IgG Assay Protocol File CD, SW4.1_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
32 | 00847865010955 | SW4.1 V1 | 6651870E | Vasculitis Assay Protocol File CD, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
33 | 00847865010948 | SW4.1_V1 | 6651670H | ToRC IgG Assay Protocol File CD, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
34 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
35 | 00847865010917 | 6632220 | 6632220 | Celiac IgG Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
36 | 00847865010900 | 6632320 | 6632320 | Celiac IgA Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
37 | 00847865010894 | 6632240 | 6632240 | Celiac IgG Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
38 | 00847865010887 | 6632340 | 6632340 | Celiac IgA Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
39 | 00847865010863 | 6652250 | 6652250 | Celiac IgG Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
40 | 00847865010856 | 6652350 | 6652350 | Celiac IgA Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
41 | 00847865010627 | 6632230 | 6632230 | Celiac IgG Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
42 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
43 | 00847865010603 | 6632200 | 6632200 | Celiac IgG Calibrator Set, | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
44 | 00847865010597 | 6632300 | 6632300 | Celiac IgA Calibrator Set | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
45 | 00847865010580 | SW4_v1 | 6652370A | Celiac IgA Assay Protocol File CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
46 | 00847865010573 | SW4_v1 | 6652270A | Celiac IgG Assay Protocol file CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
47 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
48 | 00847865004725 | SW4_V2 | 6653360E | Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2 | MXJ,MYF | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 | 2 | BioPlex 2200 |
49 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | LFZ,LKQ,LFX | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALO ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | 2 | BioPlex 2200 |
50 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | LKQ,LFX,LFZ | ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBE ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08718734961499 | Level 3 | 221.003.010 | CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
2 | 08718734961482 | Level 2 | 221.002.010 | CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
3 | 08718734961475 | Level 1 | 221.001.010 | CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. | CueSee® VeriSTAT QC | EUROTROL B.V. |
4 | 08718734961468 | 220.000.005 | CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451 | CueSee® VeriSTAT LVM | EUROTROL B.V. | |
5 | 08718734960928 | 183.000.005 | Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit. | Eurotrol | EUROTROL B.V. | |
6 | 08718734960911 | 179.003.010 | Eurotrol | EUROTROL B.V. | ||
7 | 08718734960898 | 179.002.010 | Eurotrol | EUROTROL B.V. | ||
8 | 08718734960874 | 179.001.010 | Eurotrol | EUROTROL B.V. | ||
9 | 08718734960805 | 267.000.005 | 267.000.005 | Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood g Eurotrol® epoc® Calibration Verification Fluids is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol® epoc® Calibration Verification Fluids is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol® epoc® Calibration Verification Fluids | EUROTROL B.V. |
10 | 08718734960799 | Level 6 | 266.006.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 6 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 6 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
11 | 08718734960775 | Level 3 | 266.003.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 3 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 3 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
12 | 08718734960751 | Level 2 | 266.002.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 2 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 2 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
13 | 08718734960737 | Level 1 | 266.001.010 | Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, Eurotrol epoc® GAS-ISE Metabolites - Level 1 is a single use, assayed blood gas, electrolyte and metabolite reference material for the qualitative verification of the precision and accuracy of the epoc® Blood Analysis System. The product is an in vitro diagnostic device, intended for professional laboratory personnel. Eurotrol epoc® GAS-ISE Metabolites - Level 1 is designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca2+, Mg2+, Cl-, glucose, lactate, urea, creatinine and tCO2. | Eurotrol epoc GAS-ISE Metabolites | EUROTROL B.V. |
14 | 08430793040587 | 724122 | The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celia The Celiac Disease IgA Controls include antibodies to tTG and DGP1. Aptiva Celiac IgA Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgA Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. | Aptiva® Celiac Disease IgA Controls | INOVA DIAGNOSTICS, INC. | |
15 | 08430793040570 | 724121 | The Celiac Disease IgA Calibrators include antibodies to tTG and DGP.1. Aptiva C The Celiac Disease IgA Calibrators include antibodies to tTG and DGP.1. Aptiva Celiac IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.3. Aptiva Celiac IgA Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. | Aptiva® Celiac Disease IgA Calibrators | INOVA DIAGNOSTICS, INC. | |
16 | 08430793040525 | 724102 | The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celi The Celiac Disease IgG Controls include antibodies to tTG and DGP.1. Aptiva Celiac IgG Control 1: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers and preservatives.2. Aptiva Celiac IgG Control 2: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies in stabilizers, and preservatives. | Aptiva® Celiac Disease IgG Controls | INOVA DIAGNOSTICS, INC. | |
17 | 08430793040518 | 724101 | The Celiac Disease IgG Calibrators include antibodies to tTG and DGP.1. Aptiva C The Celiac Disease IgG Calibrators include antibodies to tTG and DGP.1. Aptiva Celiac IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.3. Aptiva Celiac IgG Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. | Aptiva® Celiac Disease IgG Calibrators | INOVA DIAGNOSTICS, INC. | |
18 | 08426951346479 | 0003310350 | 00003310350 | Avox-4 CO-Oximeter Control Level 1, Level 2 and Level 3 | Avox-4 CO-Oximeter Control | INSTRUMENTATION LABORATORY COMPANY |
19 | 08426951346462 | 0003310300 | 00003310300 | Avox-4 CO-Oximeter Control, Level 3 | Avox-4 CO-Oximeter Control - L3 | INSTRUMENTATION LABORATORY COMPANY |
20 | 08426951346455 | 0003310200 | 00003310200 | Avox-4 CO-Oximeter Control, Level 2 | Avox-4 CO-Oximeter Control - L2 | INSTRUMENTATION LABORATORY COMPANY |
21 | 08426951346448 | 0003310100 | 00003310100 | Avox-4 CO-Oximeter Control, Level 1 | Avox-4 CO-Oximeter Control - L1 | INSTRUMENTATION LABORATORY COMPANY |
22 | 08426951293810 | 00044000103 | 00044000103 | ChemSTAT System Evaluator 3, 10 ampoules x 1.8 mL | ChemSTAT System Evaluator 3 | INSTRUMENTATION LABORATORY COMPANY |
23 | 08426951293803 | 00044000102 | 00044000102 | ChemSTAT System Evaluator 2, 10 ampoules x 1.8 mL | ChemSTAT System Evaluator 2 | INSTRUMENTATION LABORATORY COMPANY |
24 | 08426951293797 | 00044000101 | 00044000101 | ChemSTAT System Evaluator 1, 10 ampoules x 1.8 mL | ChemSTAT System Evaluator 1 | INSTRUMENTATION LABORATORY COMPANY |
25 | 08426951293780 | 00044001515 | 00044001515 | GEM ChemSTAT PVP1-5, 5 levels x 5 ampoules x 1.8 mL | GEM ChemSTAT PVP 1-5 | INSTRUMENTATION LABORATORY COMPANY |
26 | 08426951293773 | 00044000140 | 00044000140 | GEM ChemSTAT CVP 4, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 4 | INSTRUMENTATION LABORATORY COMPANY |
27 | 08426951293766 | 00044000130 | 00044000130 | GEM ChemSTAT CVP 3, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 3 | INSTRUMENTATION LABORATORY COMPANY |
28 | 08426951293759 | 00044000125 | 00044000125 | GEM ChemSTAT CVP 2, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 2 | INSTRUMENTATION LABORATORY COMPANY |
29 | 08426951293742 | 00044000115 | 00044000115 | GEM ChemSTAT CVP 1, 10 ampoules x 1.8 mL | GEM ChemSTAT CVP 1 | INSTRUMENTATION LABORATORY COMPANY |
30 | 08426950622208 | 701125 | 1. 1 QUANTA Flash CCP3 Reagent Cartridge2. 1 Resuspension Buffer 63. 1 Transfer pipet | QUANTA Flash® CCP3 Reagents | INOVA DIAGNOSTICS, INC. | |
31 | 08426950596080 | 701196 | 1. QUANTA Flash Centromere Calibrator 1: Two (2) barcode labeled tubes containin 1. QUANTA Flash Centromere Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL, prediluted, ready to use reagent. Calibrators contain human antibodies to centromere in buffer, stabilizers, and preservatives.2. QUANTA Flash Centromere Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL, prediluted, ready to use reagent.Calibrators contain human antibodies to centromere in buffer, stabilizers, and preservatives. | QUANTA Flash® Centromere Calibrators | INOVA DIAGNOSTICS, INC. | |
32 | 08426950595830 | 701111 | 1. QUANTA Flash DGP Screen Calibrator 1: Two (2) barcode labeled tubes with buff 1. QUANTA Flash DGP Screen Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash DGP Screen Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® DGP Screen Calibrators | INOVA DIAGNOSTICS, INC. | |
33 | 08426950595120 | 701141 | 1. QUANTA Flash GBM Calibrator 1: Two (2) barcode labeled tubes with buffer cont 1. QUANTA Flash GBM Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash GBM Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® GBM Calibrators | INOVA DIAGNOSTICS, INC. | |
34 | 08426950595083 | 701166 | 1. QUANTA Flash DGP IgA Negative Control: Two (2) barcode labeled tubes containi 1. QUANTA Flash DGP IgA Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives.2. QUANTA Flash DGP IgA Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. | QUANTA Flash® DGP IgA Calibrators | INOVA DIAGNOSTICS, INC. | |
35 | 08426950595021 | 701106 | 1. QUANTA Flash h-tTG IgG Calibrator 1: Two (2) barcode labeled tubes containing 1. QUANTA Flash h-tTG IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to h-tTG in stabilizers and preservatives. 2. QUANTA Flash h-tTG IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to h-tTG in stabilizers and preservatives. | QUANTA Flash® h-tTG IgG Calibrators | INOVA DIAGNOSTICS, INC. | |
36 | 08426950594758 | 701171 | 1. QUANTA Flash DGP IgG Calibrator 1: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash DGP IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash DGP IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives. | QUANTA Flash® DGP IgG Calibrators | INOVA DIAGNOSTICS, INC. | |
37 | 08426950593690 | 704550.10 | 1. 10 CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 5 1.2 1. 10 CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 5 1.2mL prediluted ELISA Negative Control 3. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive4. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A5. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B6. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C7. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D8. 5 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E9. 9 50mL HRP Sample Diluent10. 10 100mL High Specificity Wash Concentrate, 10x concentrate11. 10 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA12. 10 10mL TMB Chromogen13. 10 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® CCP3.1 IgG/IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
38 | 08426950593393 | 704535.10 | 1. 10x CCP3 IgG ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL 1. 10x CCP3 IgG ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted CCP3 IgG ELISA Low Positive4. 5x 1.2mL prediluted CCP3 IgG ELISA High Positive/Calibrator A5. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator B6. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator C7. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator D8. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP CCP3 IgG Conjugate, (goat), anti-human IgG12. 10 x10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® CCP3 IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
39 | 08426950573654 | 00025000103 | 00025000103 | GEM System Evaluator 3 | GEM System Evaluator 3 | INSTRUMENTATION LABORATORY COMPANY |
40 | 08426950573647 | 00025000102 | 00025000102 | GEM System Evaluator 2 | GEM System Evaluator 2 | INSTRUMENTATION LABORATORY COMPANY |
41 | 08426950573630 | 00025000101 | 00025000101 | GEM System Evaluator 1 | GEM System Evaluator 1 | INSTRUMENTATION LABORATORY COMPANY |
42 | 08426950573005 | 00003314250 | 00003314250 | Multi-4 CO-Oximeter Control, Level 2 | Multi-4 CO-Oximeter Control, Level 2 | INSTRUMENTATION LABORATORY COMPANY |
43 | 08426950566397 | 701256 | 1. QUANTA Flash ENA7 Calibrator 1: Two (2) barcode labeled tubes 0.7 mL predilut 1. QUANTA Flash ENA7 Calibrator 1: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives.2. QUANTA Flash ENA7 Calibrator 2: Two (2) barcode labeled tubes 0.7 mL prediluted, ready to use. Calibrators contain human antibodies to ENA7 in buffer, protein stabilizers, and preservatives." | QUANTA Flash® ENA7 Calibrators | INOVA DIAGNOSTICS, INC. | |
44 | 08426950554578 | 701136 | 1. QUANTA Flash PR3 Calibrator 1: Two (2) barcode labeled tubes with buffer cont 1. QUANTA Flash PR3 Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash PR3 Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.3mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® PR3 Calibrators | INOVA DIAGNOSTICS, INC. | |
45 | 08426950554547 | 701131 | 1. QUANTA Flash MPO Calibrator 1: Two (2) barcode labeled tubes with buffer cont 1. QUANTA Flash MPO Calibrator 1: Two (2) barcode labeled tubes with buffer containing human serum antibodies to MPO, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash MPO Calibrator 2: Two (2) barcode labeled tubes with buffer containing human serum antibodies to MPO, prediluted, ready to use, 0.7mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® MPO Calibrators | INOVA DIAGNOSTICS, INC. | |
46 | 08426950554509 | 701101 | 1. QUANTA Flash h-tTG IgA Calibrator 1: Two (2) barcode labeled tubes containing 1. QUANTA Flash h-tTG IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to h-tTG in stabilizers and preservatives. 2. QUANTA Flash h-tTG IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to h-tTG in stabilizers and preservatives. | QUANTA Flash® h-tTG IgA Calibrators | INOVA DIAGNOSTICS, INC. | |
47 | 08426950511519 | 00024001515 | 00024001515 | PVP Set | IL PVP | INSTRUMENTATION LABORATORY COMPANY |
48 | 08426950485704 | 00025000145 | 00025000145 | GEM CVP (Calibration Valuation Product) 5 tBili | GEM CVP (Calibration Valuation Product) 5 tBili | INSTRUMENTATION LABORATORY COMPANY |
49 | 08426950456124 | 704550 | 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive4. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A5. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B6. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C7. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D8. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 100mL High Specificity Wash Concentrate, 10x concentrate11. 1x 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® CCP3.1 IgG/IgA ELISA | INOVA DIAGNOSTICS, INC. | |
50 | 08426950453161 | 00003313250 | 00003313250 | Multi-4 CO-Oximeter Control, Level 3 | Multi-4 CO-Oximeter Control, Level 3 | INSTRUMENTATION LABORATORY COMPANY |