| 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 | 10888234002307 | 0066907 | 0066907 | Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays for the detection of IgG antibodies to red blood cells. | Capture-R Ready Indicator Red Cells | IMMUCOR, INC. |
| 2 | 10888234002178 | 0066087 | 0066087 | Monoclonal Control is intended to be used as a control for Immucor low protein B Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has one (1) vial. | Monoclonal Control | IMMUCOR, INC. |
| 3 | 10888234001751 | 0420410 | 0420410 | Gamma-clone Control is intended to be used as a control for Gamma-clone blood gr Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials. | Gamma-clone Control | IMMUCOR, INC. |
| 4 | 10888234001744 | 0420403 | 0420403 | Gamma-clone Control is intended to be used as a control for Gamma-clone blood gr Gamma-clone Control is intended to be used as a control for Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has three (3) vials. | Gamma-clone Control | IMMUCOR, INC. |
| 5 | 10888234001331 | 0066297 | 0066297 | corQC EXTEND Complete is intended for use in manual test tube and automated assa corQC EXTEND Complete is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a five vial set. | corQC EXTEND Complete | IMMUCOR, INC. |
| 6 | 10888234001324 | 0066296 | 0066296 | corQC EXTEND Standard is intended for use in manual test tube and automated assa corQC EXTEND Standard is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a single vial product. | corQC EXTEND Standard | IMMUCOR, INC. |
| 7 | 10888234001119 | 0066125 | 0066125 | DAT Positive Control Cell is designed to be used only with the Immucor automated DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the four (4) vial configuration. | DAT Positive Control Cell | IMMUCOR, INC. |
| 8 | 10888234001102 | 0066122 | 0066122 | DAT Positive Control Cell is designed to be used only with the Immucor automated DAT Positive Control Cell is designed to be used only with the Immucor automated instruments. DAT Positive Control Cells are IgG-coated red blood cells used as a control to confirm the validity of the DAT assay and other assays utilizing the direct antiglobulin test on Immucor automated instruments. This product is the one (1) vial configuration. | DAT Positive Control Cell | IMMUCOR, INC. |
| 9 | 10888234001096 | 0066090 | 0066090 | WB corQC is incorporated as a set of run controls with blood sample testing for WB corQC is incorporated as a set of run controls with blood sample testing for the daily quality control of blood bank reagents on automated instruments. A set of WB corQC is composed of four tubes of varying antigenic and antibody makeup. Each packaging of the WB corQC product contains a pair of each of the four tubes. | WB corQC | IMMUCOR, INC. |
| 10 | 10888234001089 | 0066089 | 0066089 | Monoclonal Control is intended to be used as a control for Immucor low protein B Monoclonal Control is intended to be used as a control for Immucor low protein Blood Grouping Reagents and Gamma-clone blood grouping reagents used in slide, tube, and microplate tests. This product configuration has ten (10) vials. | Monoclonal Control | IMMUCOR, INC. |
| 11 | 10888234000914 | 0007930 | 0007930 | Complement Control Cells are used in confirming reactivity of the anti-C3 compon Complement Control Cells are used in confirming reactivity of the anti-C3 component of Anti-Human Globulin, as a control mechanism for the antiglobuilin test. This product is a one (1) vial configuration. | Complement Control Cells | IMMUCOR, INC. |
| 12 | 10888234000600 | 0006428 | 0006428 | This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-S This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the ten (10) vial configuration. | Capture-R Ready Indicator Red Cells | IMMUCOR, INC. |
| 13 | 10888234000594 | 0006427 | 0006427 | This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-S This product is Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select solid phase assays for the detection of IgG antibodies to red blood cells. This product is the single vial configuration. | Capture-R Ready Indicator Red Cells | IMMUCOR, INC. |
| 14 | 10888234000372 | 0002995 | 0002995 | Weak D Cells are used for quality control of weak D testing. Weak D Cells are a Weak D Cells are used for quality control of weak D testing. Weak D Cells are a suspension of selected weak D red blood cells. This product is a one (1) vial configuration. | Weak D Cells | IMMUCOR, INC. |
| 15 | 10888234000341 | 0002417 | 0002417 | corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated a corQC EXTEND 1, 2, and 3 is intended for use in manual test tube and automated assays for quality control of routine Rh and Kell blood grouping reagents. It is a three vial set. | corQC EXTEND 1, 2, and 3 | IMMUCOR, INC. |
| 16 | 10888234000334 | 0002400 | 0002400 | corQC Test System is used for daily quality control evaluation of routine blood corQC Test System is used for daily quality control evaluation of routine blood bank reagents. It is a two vial set. One vial is a suspension of known red blood cells. The second vial is a known antiserum containing antibodies. | corQC Test System | IMMUCOR, INC. |
| 17 | 10888234000211 | 0002227 | 0002227 | Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration. | Checkcell (Weak) | IMMUCOR, INC. |
| 18 | 10888234000204 | 0002226 | 0002226 | Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration. | Checkcell (Weak) | IMMUCOR, INC. |
| 19 | 10888234000198 | 0002225 | 0002225 | Checkcell is used to confirm the validity of negative antiglobulin tests. Checkc Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration. | Checkcell | IMMUCOR, INC. |
| 20 | 10888234000181 | 0002224 | 0002224 | Checkcell is used to confirm the validity of negative antiglobulin tests. Checkc Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration. | Checkcell | IMMUCOR, INC. |
| 21 | 10758750007554 | 6902096 | 6902096 | ORTHO® Confidence System | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 22 | 10758750005949 | MTS081001 | MTS081001 | MTS Monoclonal Control Card | MTS | MICRO TYPING SYSTEMS, INC |
| 23 | 10758750004072 | 719810 | 719810 | Reagent Red Blood Cells (Pooled Cells) Ortho® Coombs Control | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 24 | 07611969952502 | 816030100 | 816030100 | IgG-coated red blood cells for the control of antiglobulin test; 10ml | Coombscell-E | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| 25 | 07611969952342 | 814172100 | For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- For manual Quality Control testing, Set of 5x4 mL red cells in suspension (4 +/- 1%) and 3x3 mL sera (human, polyclonal) | IH-Internal QC | BIO-RAD MEDICAL DIAGNOSTICS GMBH | |
| 26 | 07611969952335 | 814171100 | Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing Set of 2 x 8 x5 mL pooled whole blood (15.0 ± 2.0%) for quality control testing for use with the IH-System | IH-Basic QC | BIO-RAD MEDICAL DIAGNOSTICS GMBH | |
| 27 | 07611969952212 | 813600100 | 813600100 | Optional card for the negative control in ABO and Rh typing; 12 cards of 6 microtubes | IH-Card Control | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| 28 | 07611969950874 | 805171100 | 805171100 | Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh Reagent for the negative control in ABO and RH typing with Seraclone ABO and Rh reagent for tube test; 10 ml | Seraclone Control AB0+Rh | BIO-RAD MEDICAL DIAGNOSTICS GMBH |
| 29 | 05060242472473 | Z271U | ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control ALBAcheck - BGS Monoclonal Control is designed to be used as a negative control in conjunction with Alba Bioscience Limited monoclonal blood grouping reagents (where referenced in the reagent IFU). | ALBAcheck - BGS Monoclonal Control | ALBA BIOSCIENCE LIMITED | |
| 30 | 05060242472329 | Z443U | These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglo These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT). | ALBAcyte IgG Sensitized Red Blood Cells II | ALBA BIOSCIENCE LIMITED | |
| 31 | 05060242471612 | Z482U | For control of the indirect and direct antiglobulin test. ALBAcyte® C3 Coated R For control of the indirect and direct antiglobulin test. ALBAcyte® C3 Coated Red Blood Cells is used as a control to confirm the presence or absence of Anti-C3 reactivity of Anti-Human Globulin Reagent and as indicator cells in AHG testing. | ALBAcyte C3 Coated Red Blood Cells | ALBA BIOSCIENCE LIMITED | |
| 32 | 05060242471513 | Z271U | ALBAcheck BGS Reagent Control for Anti-D. | ALBAcheck BGS Reagent Control for Anti-D | ALBA BIOSCIENCE LIMITED | |
| 33 | 05060242471353 | Z481U | Qualitative controls for the quality control of routine blood bank reagents. The Qualitative controls for the quality control of routine blood bank reagents. The ALBAsure® QC Kit is intended for daily use to evaluate ABO, RhD and antibody screening reagents by manual blood grouping methods. | ALBAsure QC Kit | ALBA BIOSCIENCE LIMITED | |
| 34 | 05060242471162 | Z441U | ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect a ALBAcyte IgG Sensitized Red Blood Cells for control of the direct and indirect antiglobulin test. | ALBAcyte IgG Sensitized Red Blood Cells | ALBA BIOSCIENCE LIMITED | |
| 35 | 05060242470943 | Z498 | AlbaQ-Chek® is intended for use as ABO, RhD and antibody screening controls for AlbaQ-Chek® is intended for use as ABO, RhD and antibody screening controls for automated/semi-automated blood grouping systems using column agglutination techniques. | AlbaQ-Chek® | ALBA BIOSCIENCE LIMITED | |
| 36 | 00858400005091 | 510400/510402 | IgG-coated red blood cells used to confirm negative results in direct antiglobul IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT). | Control Cells | AMERICAN NATIONAL RED CROSS | |
| 37 | 00858400005084 | 510395 | Blood Bank kit used to perform quality control testing of reverse grouping and s Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells. | DailyChek QC Kit | AMERICAN NATIONAL RED CROSS | |
| 38 | 00858352006139 | H9350 | MQC-CAT is intended for the quality control of routine blood bank reagents when MQC-CAT is intended for the quality control of routine blood bank reagents when tested by CAT techiques. | MQC-CAT | HEMO BIOSCIENCE INC | |
| 39 | 00858352006122 | H9300 | MQC is intended for the quality control of routine blood bank reagents when test MQC is intended for the quality control of routine blood bank reagents when tested by tube technique. | MQC | HEMO BIOSCIENCE INC | |
| 40 | 00858352006016 | H9000 | H9000 | C3 Control Cells are used to confirm the reactivity of anti-C3 in Anti-human globulin. | C3 Control Cells | HEMO BIOSCIENCE INC |
| 41 | 00858352006009 | H9200 | H9200 | Hemo-QC simulates blood samples and is intended for the daily quality control of Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems. | Hemo-QC | HEMO BIOSCIENCE INC |
| 42 | 00847661005780 | 00102C | 00102C | VIROTROL I (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 43 | 00847661005773 | 00102B | 00102B | VIROTROL I (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 44 | 00847661005629 | 00115B | 00115B | VIROTROL II (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 45 | 00847661005612 | 00105C | 00105C | VIROTROL HIV-2 (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 46 | 00847661005605 | 00105B | 00105B | VIROTROL HIV-2 (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 47 | 00847661005599 | 00105A | 00105A | VIROTROL HIV-2 (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 48 | 00847661005582 | 00108B | 00108B | VIROTROL HIV-1 Ag (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 49 | 00847661005551 | 00101G | 00101G | VIROTROL I (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |
| 50 | 00847661005544 | 00101F | 00101F | VIROTROL I (An unassayed (human) serological control.) | VIROTROL | BIO-RAD LABORATORIES, INC. |