| 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 | 00845714004247 | 2308-1 | 2308-1 | WASH BUFFER | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 2 | 00845714002960 | 5308 | 5308 | Serum Diluent | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 3 | 00845714002922 | 2514 | 2514 | TMB Substrate | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 4 | 00845714002786 | 2316 | 2316 | Stop Solution | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 5 | 00845714002670 | 5117A | 5117A | ImmuLisa anti-gliadin IgA ELISA | Immco Diagnostics, Inc. | IMMCO DIAGNOSTICS, INC. |
| 6 | 00845714002663 | 5117G | 5117G | ImmuLisa anti-gliadin IgG ELISA | Immco Diagnostics, Inc. | IMMCO DIAGNOSTICS, INC. |
| 7 | 00845714001857 | 5159A | 5159A | Celiac G+lgA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 8 | 00845714001840 | 5159G | 5159G | Celiac G+lgG | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 9 | 00845714000058 | 1117G | 1117G | Anti-gliadin IgG antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 10 | 00845714000041 | 1117A | 1117A | Anti-gliadin IgA antibody ELISA | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. |
| 11 | 00816879020205 | FGA20 | 96 well ELISA for the detection of IgA Gliadin antibodies in human serum | Autostat II Anti-Gliadin IgA | HYCOR BIOMEDICAL LLC | |
| 12 | 00816879020199 | FGA19 | 96 well ELISA for the detection of IgG Gliadin antibodies in human serum | Autostat II Anti-Gliadin IgG | HYCOR BIOMEDICAL LLC | |
| 13 | 08430793040532 | 724120 | 1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples.a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative.d. Rehydration Buffer - containing protein stabilizers and preservatives | Aptiva® Celiac Disease IgA Reagent | INOVA DIAGNOSTICS, INC. | |
| 14 | 08430793040471 | 724100 | 1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples. 1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples.a. tTG, DGP, and Control paramagnetic particles, preserved. b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.d. Rehydration Buffer - containing protein stabilizers and preservatives | Aptiva® Celiac Disease IgG Reagent | INOVA DIAGNOSTICS, INC. | |
| 15 | 08426950627753 | 701170 | 1 QUANTA Flash DGP IgG Reagent Cartridge | QUANTA Flash® DGP IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 16 | 08426950595731 | 701113 | 1. 1 QUANTA Flash DGP Screen Reagent Cartridge | QUANTA Flash® DGP Screen Reagents | INOVA DIAGNOSTICS, INC. | |
| 17 | 08426950594079 | 704520.10 | 1. 10x Gliadin IgG II ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1. 10x Gliadin IgG II ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Gliadin IgG II ELISA Low Positive4. 5x 1.2mL prediluted Gliadin IgG II ELISA High Positive5. 9 x50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 10x 10mL TMB Chromogen9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Gliadin IgG II ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 18 | 08426950594024 | 704520.10L | 1. 10x Gliadin IgG II ELISA Plate2. 5x 1.2mL Gliadin IgG II ELISA Low Positive3. 1. 10x Gliadin IgG II ELISA Plate2. 5x 1.2mL Gliadin IgG II ELISA Low Positive3. 5x 1.2mL Gliadin IgG II ELISA High Positive4. 10x 10mL HRP IgG Conjugate5. 10x 10mL TMB Chromogen6. 10x 10mL HRP Stop Solution7. 9 x50mL HRP Sample Diluent8. 10x 25mL HRP Wash Concentrate, 40x concentrate9. 5x 1.2mL ELISA Negative Control | QUANTA LITE® Gliadin IgG II ELISA Bulk Pack (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 19 | 08426950593973 | 704525.10L | 1. 10x Gliadin IgA II ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1. 10x Gliadin IgA II ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Gliadin IgA II ELISA Low Positive 4. 5x 1.2mL prediluted Gliadin IgA II ELISA High Positive5. 10x 25mL HRP Wash Concentrate, 40x concentrate6. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA7. 10x 10mL TMB Chromogen8. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid9. 9x 50mL HRP Sample Diluent | QUANTA LITE® Gliadin IgA II ELISA Bulk Pack Lab Corp | INOVA DIAGNOSTICS, INC. | |
| 20 | 08426950593546 | 704525.10 | 1. 10x Gliadin IgA II ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1. 10x Gliadin IgA II ELISA microwell plates (12-1 x 8 wells), with holder 2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Gliadin IgA II ELISA Low Positive 4. 5x 1.2mL prediluted Gliadin IgA II ELISA High Positive 9 50x mL HRP Sample Diluent5. 10x 25mL HRP Wash Concentrate, 40x concentrate6. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA7. 10x 10mL TMB Chromogen8. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Gliadin IgA II ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 21 | 08426950593324 | 704545 | 1. 1x Celiac DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1x Celiac DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Celiac DGP Screen ELISA Low Positive4. 1x 1.2mL prediluted Celiac DGP Screen ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP Ig G/A Conjugate, (goat), anti-human IgG and IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Celiac DGP Screen ELISA | INOVA DIAGNOSTICS, INC. | |
| 22 | 08426950593300 | 704575 | 1. 1x h-tTG/DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1 1. 1x h-tTG/DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA Low Positive4. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP h-tTG/DGP IgG/IgA, (goat), anti-human IgG and IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® h-tTG /DGP Screen ELISA | INOVA DIAGNOSTICS, INC. | |
| 23 | 08426950544173 | 701168 | 1. 1 QUANTA Flash DGP IgA Reagent Cartridge | QUANTA Flash® DGP IgA Reagents | INOVA DIAGNOSTICS, INC. | |
| 24 | 08426950544166 | 701173 | 1. 1 QUANTA Flash DGP IgG Reagent Cartridge | QUANTA Flash® DGP IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 25 | 08426950485995 | 708655 | 1. 1x Gliadin IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Gliadin IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgA ELISA Low Positive4. 1x 1.2mL prediluted Gliadin IgA ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Gliadin IgA ELISA | INOVA DIAGNOSTICS, INC. | |
| 26 | 08426950454519 | 708650 | 1 .1x Gliadin IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1 .1x Gliadin IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgG ELISA Low Positive4. 1x 1.2mL prediluted Gliadin IgG ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Gliadin IgG ELISA | INOVA DIAGNOSTICS, INC. | |
| 27 | 08426950448334 | 704525 | 1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1. 1x Gliadin IgA II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgA II ELISA Low Positive4. 1x.2mL prediluted Gliadin IgA II ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Gliadin IgA II ELISA | INOVA DIAGNOSTICS, INC. | |
| 28 | 08426950448327 | 704520 | 1. 1x Gliadin IgG II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1. 1x Gliadin IgG II ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Gliadin IgG II ELISA Low Positive4. 1x 1.2mL prediluted Gliadin IgG II ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Gliadin IgG II ELISA | INOVA DIAGNOSTICS, INC. | |
| 29 | 08028169204086 | 9178 | 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (Igg):1x15 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (Igg):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 10, 20, 50 and 100 AU/ml).4. Control 1: 1x1.5 mL vial.5. Control 2: 1x1.5 mL vial.6. Sample Diluent (10x): 1 x20mL vial.7. Substrate: 1 x15 ml vial.8. Wash solution (20x): 1x50 mL vial.9. Stop Solution: 1 x15 ml vial. | a-GliaPep IgG | EUROSPITAL SPA | |
| 30 | 08028169204079 | 9177 | 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgA):1x15 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgA):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 10, 20, 50 and 100 AU/ml).4. Control 1: 1x1.5 mL vial.5. Control 2: 1x1.5 mL vial.6. Sample Diluent (10x): 1 x20mL vial.7. Substrate: 1 x15 ml vial.8. Wash solution (20x): 1x50 mL vial.9. Stop Solution: 1 x15 ml vial. | a-GliaPep IgA | EUROSPITAL SPA | |
| 31 | 08028169204055 | 9167 | 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgA):1x15 1. Antibody coated plate: 12-1 x 8 wells.2. Enzyme conjugate antibody (IgA):1x15mL vial.3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 10, 20, 50 and 100 AU/ml).4. Control 1: 1x1.5 mL vial.5. Control 2: 1x1.5 mL vial.6. Sample Diluent (10x): 1 x20mL vial.7. Substrate: 1 x15 ml vial.8. Wash solution (20x): 1x50 mL vial.9. Stop Solution: 1 x15 ml vial. | a-Gliatest IgA | EUROSPITAL SPA | |
| 32 | 07333066019925 | 34-2332-61 | 34-2332-61 | ImmunoCAP Gliadin IgG Control High | ImmunoCAP Gliadin IgG Control High | PHADIA AB |
| 33 | 07333066019918 | 34-2332-51 | 34-2332-51 | ImmunoCAP Gliadin IgA Control High | ImmunoCAP Gliadin IgA Control High | PHADIA AB |
| 34 | 07333066019901 | 34-2332-41 | 34-2332-41 | ImmunoCAP Gliadin IgA/IgG Control Low | ImmunoCAP Gliadin IgA/IgG Control Low | PHADIA AB |
| 35 | 07333066019819 | 34-2293-41 | 34-2293-41 | ImmunoCAP Specific IgA/IgG Sample Diluent | ImmunoCAP Specific IgA/IgG Sample Diluent | PHADIA AB |
| 36 | 07333066019574 | 10-9308-01 | 10-9308-01 | Contains three vials of each Specific IgA Curve Control (CC-1, CC-2) for the Imm Contains three vials of each Specific IgA Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgA method. | ImmunoCAP Specific IgA Curve Controls | PHADIA AB |
| 37 | 07333066019550 | 10-9304-01 | 10-9304-01 | Contains one vial of each Specific IgA Calibrator (Cal-0.01, Cal-0.02, Cal-0.04, Contains one vial of each Specific IgA Calibrator (Cal-0.01, Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0) to form a complete calibration curve for the ImmunoCAP Specific IgA method. | ImmunoCAP Specific IgA Calibrators | PHADIA AB |
| 38 | 07333066014807 | DECC055390 | DECC055390 | EliA GliadinDP IgG Well | EliA GliadinDP IgG Well | PHADIA AB |
| 39 | 07333066014791 | DECC055380 | DECC055380 | EliA GliadinDP IgA Well | EliA GliadinDP IgA Well | PHADIA AB |
| 40 | 07333066014692 | DECC055200 | DECC055200 | EliA Gliadin IgG Well | EliA Gliadin IgG Well | PHADIA AB |
| 41 | 07333066014685 | DECC055190 | DECC055190 | EliA Gliadin IgA Well | EliA Gliadin IgA Well | PHADIA AB |
| 42 | 07333066012230 | 34-2328-11 | 34-2328-11 | ImmunoCAP Specific IgA Conjugate | ImmunoCAP Specific IgA Conjugate | PHADIA AB |
| 43 | 07333066003757 | 14-4425-01 | 14-4425-01 | ImmunoCAP Antigen AGf98, Gliadin | ImmunoCAP Antigen AGf98, Gliadin | PHADIA AB |
| 44 | 07333066003740 | 14-4424-01 | 14-4424-01 | ImmunoCAP IgA/IgG Calibrator ImmunoCAP | ImmunoCAP IgA/IgG Calibrator ImmunoCAP | PHADIA AB |
| 45 | 04250289504843 | 30-7515US | 30-7515US | AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme im AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the combined semiquantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum.30'+30'+30' automation incubation. | AESKULISA® DGP-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 46 | 04250289504591 | 30-7514US | 30-7514US | AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation. | AESKULISA® DGP-G | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 47 | 04250289504584 | 30-7513US | 30-7513US | AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation. | AESKULISA® DGP-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 48 | 04250289503679 | 3515 | AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, dea AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the combined quantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | AESKULISA® DGP-Check | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 49 | 04250289503631 | 3514 | AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | AESKULISA® DGP-G | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 50 | 04250289503624 | 3513 | AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | AESKULISA® DGP-A | AESKU.DIAGNOSTICS GMBH & CO. KG |