| 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 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
| 42 | 00847865010603 | 6632200 | 6632200 | Celiac IgG Calibrator Set, | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
| 43 | 00847865010597 | 6632300 | 6632300 | Celiac IgA Calibrator Set | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
| 44 | 00847865010580 | SW4_v1 | 6652370A | Celiac IgA Assay Protocol File CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 45 | 00847865010573 | SW4_v1 | 6652270A | Celiac IgG Assay Protocol file CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 46 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
| 47 | 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 |
| 48 | 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 |
| 49 | 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 |
| 50 | 00847865002998 | SW4_1 | 6652165A | Manual & CDs, APLS IgA IFU, SW4_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 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08718734961406 | 025.000.005 | GlucoLin is an assayed glucose control intended for professional use in the veri GlucoLin is an assayed glucose control intended for professional use in the verification of the linearity of the HemoCue® Glucose systems.A box of GlucoLin contains 5 levels of control material:GlucoLin XLow: 08718734961352GlucoLin Low: 08718734961369GlucoLin Normal: 08718734961376GlucoLin High: 08718734961383GlucoLin XHigh: 08718734961390 | GlucoLin | EUROTROL B.V. | |
| 2 | 08718734960935 | 180.013.002 | Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional us Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer.A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material:GlucoTrol-AQ Low (1): 08718734961536GlucoTrol-AQ High (3): 08718734961543 | Eurotrol GlucoTrol-AQ | EUROTROL B.V. | |
| 3 | 08718734960645 | AlbuTrol Level 2 | 189.002.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |
| 4 | 08718734960621 | AlbuTrol Level 1 | 189.001.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |
| 5 | 08718734960607 | GlucoTrol-NG Level 4 | 170.004.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 6 | 08718734960584 | GlucoTrol-NG Level 3 | 170.003.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 7 | 08718734960560 | GlucoTrol-NG Level 2 | 170.002.002 | Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional us Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems. | Eurotrol GlucoTrol-NG | EUROTROL B.V. |
| 8 | 08426951301706 | 00009800022 | 00009800022 | 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tube 1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. | HemosIL AcuStar Anti-B2GPI Domain 1 Controls | INSTRUMENTATION LABORATORY COMPANY |
| 9 | 08426950928782 | 701352 | 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containi 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin High Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. | QUANTA Flash® Calprotectin Controls | INOVA DIAGNOSTICS, INC. | |
| 10 | 08426950869320 | 701347 | 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Postitive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives. | QUANTA Flash RF IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 11 | 08426950845263 | 701342 | 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. | QUANTA Flash RF IgM Controls | INOVA DIAGNOSTICS, INC. | |
| 12 | 08426950793175 | 701332 | 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives.2. QUANTA Flash HMGCR Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives. | QUANTA Flash® HMGCR Controls | INOVA DIAGNOSTICS, INC. | |
| 13 | 08426950766995 | 701297 | 1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash LKM-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers and preservatives.2. QUANTA Flash LKM-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to LKM-1 in stabilizers, and preservatives." | QUANTA Flash® LKM-1 Controls | INOVA DIAGNOSTICS, INC. | |
| 14 | 08426950730095 | 701302 | 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers, and preservatives. | QUANTA Flash® M2 (MIT3) Controls | INOVA DIAGNOSTICS, INC. | |
| 15 | 08426950724483 | 701327 | 1. QUANTA Flash Scl-70 Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash Scl-70 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Scl-70 in stabilizers and preservatives.2. QUANTA Flash Scl-70 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Scl-70 in stabilizers, and preservatives. | QUANTA Flash® Scl-70 Controls | INOVA DIAGNOSTICS, INC. | |
| 16 | 08426950622192 | 701127 | 1. QUANTA Flash CCP3 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash CCP3 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to CCP3 in stabilizers and preservatives.2. QUANTA Flash CCP3 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to CCP3 in stabilizers, and preservatives. | QUANTA Flash® CCP3 Controls | INOVA DIAGNOSTICS, INC. | |
| 17 | 08426950601944 | 701187 | 1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes o 1. QUANTA Flash ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.2. QUANTA Flash ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. | QUANTA Flash® B2GP1-Domain1 Controls | INOVA DIAGNOSTICS, INC. | |
| 18 | 08426950601920 | 701177 | 1. QUANTA Flash dsDNA Low Control: Two (2) barcode labeled tubes containing 0.7 1. QUANTA Flash dsDNA Low Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers and preservatives.2. QUANTA Flash dsDNA High Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers, and preservatives. | QUANTA Flash® dsDNA Controls | INOVA DIAGNOSTICS, INC. | |
| 19 | 08426950597483 | 701227 | 1. QUANTA Flash aCL IgA Low Control: 3 x 1 mL barcoded tubes of a solution with 1. QUANTA Flash aCL IgA Low Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative.2. QUANTA Flash aCL IgA High Control: 3 x 1 mL barcoded tubes of a solution with aCL IgA in phosphate buffer, containing fetal bovine serum, stabilizers and preservative. | QUANTA Flash® aCL IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 20 | 08426950597353 | 701242 | 1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution wit 1. QUANTA Flash ß2GP1 IgA Low Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative.2. QUANTA Flash ß2GP1 IgA High Control: 3 x 1 mL barcoded tubes of a solution with anti- ß2GP1 IgA in phosphate buffer, containing bovine serum albumin, stabilizers and preservative. | QUANTA Flash® β2GPI IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 21 | 08426950597063 | 701147 | 1. QUANTA Flash Ro60 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash Ro60 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro60 in stabilizers and preservatives.2. QUANTA Flash Ro60 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro60 in stabilizers, and preservatives. | QUANTA Flash® Ro60 Controls | INOVA DIAGNOSTICS, INC. | |
| 22 | 08426950597056 | 701152 | 1. QUANTA Flash SS-B Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash SS-B Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to SS-B in stabilizers and preservatives.2. QUANTA Flash SS-B Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to SS-B in stabilizers, and preservatives. | QUANTA Flash® SS-B Controls | INOVA DIAGNOSTICS, INC. | |
| 23 | 08426950596660 | 701262 | 1. QUANTA Flash Ro52 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash Ro52 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in stabilizers and preservatives.2. QUANTA Flash Ro52 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Ro52 in stabilizers, and preservatives. | QUANTA Flash® Ro52 Controls | INOVA DIAGNOSTICS, INC. | |
| 24 | 08426950596097 | 701197 | 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes conta 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives.2. QUANTA Flash Centromere Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives. | QUANTA Flash® Centromere Controls | INOVA DIAGNOSTICS, INC. | |
| 25 | 08426950596073 | 701117 | 1. QUANTA Flash RNP Negative Control: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash RNP Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to RNP in stabilizers and preservatives.2. QUANTA Flash RNP Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to RNP in stabilizers and preservatives. | QUANTA Flash® RNP Controls | INOVA DIAGNOSTICS, INC. | |
| 26 | 08426950596035 | 701122 | 1. QUANTA Flash Sm Negative Control: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash Sm Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Sm in stabilizers and preservatives.2. QUANTA Flash Sm Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Sm in stabilizers, and preservatives. | QUANTA Flash® Sm Controls | INOVA DIAGNOSTICS, INC. | |
| 27 | 08426950596011 | 701162 | 1. QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash Jo-1 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in the buffer, stabilizers, and preservatives.2. QUANTA Flash Jo-1 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to Jo-1 in the buffer, stabilizers, and preservatives. | QUANTA Flash® Jo-1 Controls | INOVA DIAGNOSTICS, INC. | |
| 28 | 08426950595847 | 701112 | 1. QUANTA Flash DGP Screen Negative Control: Two (2) barcode labeled tubes with 1. QUANTA Flash DGP Screen Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash DGP Screen Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to DGP, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® DGP Screen Controls | INOVA DIAGNOSTICS, INC. | |
| 29 | 08426950595250 | 701247 | 1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with 1. QUANTA Flash ß2GP1 IgG Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albimun, stabilizers and preservative.2. QUANTA Flash ß2GP1 IgG High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgG in phosphate buffer containing bovine serum albumin, stabilizers and preservative. | QUANTA Flash® β2GPI IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 30 | 08426950595038 | 701252 | 1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with 1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative.2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative. | QUANTA Flash® β2GPI IgM Controls | INOVA DIAGNOSTICS, INC. | |
| 31 | 08426950594994 | 701237 | 1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with a 1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum stabilizers and preservative.2. QUANTA Flash aCL IgM High Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum, stabilizers and preservative. | QUANTA Flash® aCL IgM Controls | INOVA DIAGNOSTICS, INC. | |
| 32 | 08426950594888 | 701142 | 1. QUANTA Flash GBM Negative Control: Two (2) barcode labeled tubes with buffer 1. QUANTA Flash GBM Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash GBM Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® GBM Controls | INOVA DIAGNOSTICS, INC. | |
| 33 | 08426950594765 | 701107 | 1. QUANTA Flash h-tTG IgG Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash h-tTG IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to h-tTG in stabilizers and preservatives.2. QUANTA Flash h-tTG IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to h-tTG in stabilizers, and preservatives. | QUANTA Flash® h-tTG IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 34 | 08426950594413 | 701172 | 1. QUANTA Flash DGP IgG Negative Control: Two (2) barcode labeled tubes containi 1. QUANTA Flash DGP IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.2. QUANTA Flash DGP IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives. | QUANTA Flash® DGP IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 35 | 08426950566380 | 701257 | 1. QUANTA Flash ENA7 Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash ENA7 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives.2. QUANTA Flash ENA7 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to ENA7 in buffer, stabilizers, and preservatives." | QUANTA Flash® ENA7 Controls | INOVA DIAGNOSTICS, INC. | |
| 36 | 08426950557579 | 701167 | 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. | QUANTA Flash® DGP IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 37 | 08426950554561 | 701132 | 1. QUANTA Flash MPO Negative Control: Two (2) barcode labeled tubes with buffer 1. QUANTA Flash MPO Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to MPO, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash MPO Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to MPO, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® MPO Controls | INOVA DIAGNOSTICS, INC. | |
| 38 | 08426950554554 | 701137 | 1. QUANTA Flash PR3 Negative Control: Two (2) barcode labeled tubes with buffer 1. QUANTA Flash PR3 Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash PR3 Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). | QUANTA Flash® PR3 Controls | INOVA DIAGNOSTICS, INC. | |
| 39 | 08426950554493 | 701102 | 1. QUANTA Flash h-tTG IgA Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash h-tTG IgA Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to h-tTG in stabilizers and preservatives.2. QUANTA Flash h-tTG IgA Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to h-tTG in stabilizers and preservatives. | QUANTA Flash® h-tTG IgA Controls | INOVA DIAGNOSTICS, INC. | |
| 40 | 08426950554486 | 701232 | 1. QUANTA Flash aCL IgG Low Control 3 x 1 mL barcoded tubes of a solution with a 1. QUANTA Flash aCL IgG Low Control 3 x 1 mL barcoded tubes of a solution with aCL IgG in saline solution containing fetal bovine serum stabilizers and preservative.2. QUANTA Flash aCL IgG High Control 3 x 1 mL barcoded tubes of a solution with aCL IgG in saline solution containing fetal bovine serum, stabilizers and preservative. | QUANTA Flash® aCL IgG Controls | INOVA DIAGNOSTICS, INC. | |
| 41 | 08426950497028 | 0009802116 | 0009802116 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls | INSTRUMENTATION LABORATORY COMPANY |
| 42 | 08426950497011 | 0009802112 | 0009802112 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls | INSTRUMENTATION LABORATORY COMPANY |
| 43 | 08426950497004 | 0009802108 | 0009802108 | HemosIL AcuStar Anti-Cardiolipin IgM Controls | HemosIL AcuStar Anti-Cardiolipin IgM Controls | INSTRUMENTATION LABORATORY COMPANY |
| 44 | 08426950496991 | 0009802104 | 0009802104 | HemosIL AcuStar Anti-Cardiolipin IgG Controls | HemosIL AcuStar Anti-Cardiolipin IgG Controls | INSTRUMENTATION LABORATORY COMPANY |
| 45 | 08426950453031 | 00020007900 | 00020007900 | HemosIL Homocysteine Controls | HemosIL Homocysteine Controls | INSTRUMENTATION LABORATORY COMPANY |
| 46 | 08058056682314 | 04Y85-11 | 04Y85-11 | Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG Lipase NG OC CTRL 2 must be used only to verify the performance of the Lipase NG.Use the Control Material like the specimens, according to the indicated analytical procedure. | Lipase NG OC CTRL 2 | SENTINEL CH. SPA |
| 47 | 08058056682307 | 04Y85-10 | 04Y85-10 | Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG Lipase NG OC CTRL 1 must be used only to verify the performance of the Lipase NG.Use the Control Material like the specimens, according to the indicated analytical procedure. | Lipase NG OC CTRL 1 | SENTINEL CH. SPA |
| 48 | 08058056681775 | 1667001 | 1667001 | ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monit ACE Control Set is intended to be used with Sentinel ACE Liquid Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. For In Vitro Diagnostic use. | ACE Control Set | SENTINEL CH. SPA |
| 49 | 07613336198919 | 09108912190 | 09108912190 | Vitamin D total G3 CC 5 Elecsys | CalCheck Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
| 50 | 07613336172674 | 09038124190 | 09038124190 | Vitamin D total G2 PC Elecsys V2 | PreciControl Vitamin D total III | ROCHE DIAGNOSTICS GMBH |