| 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 | 00816426021273 | K92C-4M | K92C-4M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer. | K-ASSAY® D-Dimer Control | KAMIYA BIOMEDICAL COMPANY, LLC |
| 2 | 00816426021266 | K92C-2M | K92C-2M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer. | K-ASSAY® D-Dimer Control | KAMIYA BIOMEDICAL COMPANY, LLC |
| 3 | 00816426020870 | K63C-10M | K63C-10M | For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for fibrinogen. | K-ASSAY® Fibrinogen Control | KAMIYA BIOMEDICAL COMPANY, LLC |
| 4 | 00815696021303 | 0001-60.0 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 5 | 00815696021297 | 0010-60.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma is intend George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. it may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 6 | 00815696021280 | 4000-200.0 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay. | George King Coumadin® Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 7 | 00815696021266 | 1402-50.0 | George King von Willebrand plasma, Type 2B, is a citrated human fresh frozen pla George King von Willebrand plasma, Type 2B, is a citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type 2B. This plasma is intended for use as a control in the quantitative determination of von Willebrand factor antigen in citrated plasma. | George King von Willebrand Plasma, Type 2B | GEORGE KING BIO-MEDICAL, INC | |
| 8 | 00815696021259 | 0010-10.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged PT or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 9 | 00815696021228 | 0001-50.0 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 10 | 00815696021204 | 0075-20 | George King Single Donor Normal Control Kit contains fresh frozen citrated human George King Single Donor Normal Control Kit contains fresh frozen citrated human plasmas derived from non-medicated, non-smoking donors between the ages of 18 and 65 years of age. The kit is intended for use in establishing controlling reference ranges for coagulation assays. | George King SDN Control Kit | GEORGE KING BIO-MEDICAL, INC | |
| 11 | 00815696021198 | 0010-500.0 | George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged PT and.or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 12 | 00815696021181 | 1800-50 | George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor whohas developed an antibody to FVIII. | George King Factor VIII Deficient Plasma with Inhibitor | GEORGE KING BIO-MEDICAL, INC | |
| 13 | 00815696021174 | 1800-100 | George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII. | George King Factor VIII Deficient Plasma with Inhibitor | GEORGE KING BIO-MEDICAL, INC | |
| 14 | 00815696021167 | 1800-250 | George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII | George King Factor VIII Deficient Plasma with Inhibitor | GEORGE KING BIO-MEDICAL, INC | |
| 15 | 00815696021136 | 4000-330.0 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay. | George King Coumadin® Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 16 | 00815696021129 | 4000-300.0 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay. | George King Coumadin® Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 17 | 00815696021105 | 0001-0.5 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 18 | 00815696021099 | 0090-30 | The George King Coumadin® Plasma Kit is a convenience control kit that contains The George King Coumadin® Plasma Kit is a convenience control kit that contains citrated human fresh frozen plasma from donors on Coumadin® therapy. Each kit contains control material with six different INR levels. | George King Coumadin® Plasma Convenience Kit | GEORGE KING BIO-MEDICAL, INC | |
| 19 | 00815696021044 | 0010-180.0 | George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) ad/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 20 | 00815696020719 | 9400 - 25 | George King Multi-Coumadin® Kit is citrated fresh frozen human plasma derived fr George King Multi-Coumadin® Kit is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay. | George King Multi-Coumadin® Kit | GEORGE KING BIO-MEDICAL, INC | |
| 21 | 00815696020603 | 0001 - 50.0 | George King Single Donor Normal Plasma is fresh frozen human citrated plasma and George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 22 | 00815696020597 | 0001-100.0 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Normal Donor Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 23 | 00815696020580 | 0030-1.5 | George King A-FACT is a low abnormal fresh frozen citrated control that is used George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King A-FACT | GEORGE KING BIO-MEDICAL, INC | |
| 24 | 00815696020573 | 0040-1.5 | George King B-FACT is a borderline normal fresh frozen citrated control that is George King B-FACT is a borderline normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King B-FACT | GEORGE KING BIO-MEDICAL, INC | |
| 25 | 00815696020566 | 0020-1.5 | George King FACT is a normal fresh frozen citrated control that is used to verif George King FACT is a normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King FACT | GEORGE KING BIO-MEDICAL, INC | |
| 26 | 00815696020559 | 0001-1.5 | George King Single Donor Normal Plasma is fresh frozen citrared human plasma and George King Single Donor Normal Plasma is fresh frozen citrared human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 27 | 00815696020542 | 0010-240.0 | George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 28 | 00815696020535 | 0010-150.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 29 | 00815696020528 | 0010-125.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 30 | 00815696020511 | 0070-50 | George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated huma George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived from non-mediated, non-smoking donors between the ages of 18-56 years of age. The kit contains 25 males and 25 females and is intended for use in establishing reference ranges for coagulation assays. | George King CORE Kit | GEORGE KING BIO-MEDICAL, INC | |
| 31 | 00815696020504 | 0070 - 30 | George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated huma George King Control Of Range Evaluation (CORE) Kit is fresh frozen citrated human plasma derived from non-mediated, non-smoking donors between the ages of 18-56 years of age. The kit contains 15 males and 15 females and is intended for use in establishing reference ranges for coagulation assays. | George King CORE Kit | GEORGE KING BIO-MEDICAL, INC | |
| 32 | 00815696020498 | 0065-35 | SysCOR Plus is a System Control convenience kit which contains different levels SysCOR Plus is a System Control convenience kit which contains different levels of control material that can be used to correlate results when changing lot numbers of reagents and/or instrument platforms. Similar to the SysCOR kit but with five additional Coumadin® control plasmas. | George King SysCOR Plus Kit | GEORGE KING BIO-MEDICAL, INC | |
| 33 | 00815696020481 | 0065-30 | SysCOR is a System Control convenience kit which contains different levels of co SysCOR is a System Control convenience kit which contains different levels of control material that can be used to correlate results when changing lot numbers of reagents and/or instrument platforms. | George King SysCOR Kit | GEORGE KING BIO-MEDICAL, INC | |
| 34 | 00815696020474 | 0014-10 | The AMR von Willebrand Kit is a convenience kit that contains five levels of cit The AMR von Willebrand Kit is a convenience kit that contains five levels of citrated human fresh frozen control material that can be used to verify the analytical measurement range of vWF Ag. | George King AMR von Willebrand Kit | GEORGE KING BIO-MEDICAL, INC | |
| 35 | 00815696020467 | 0014-30 | The AMR Coagulation Kit is a convenience kit that contains three levels of contr The AMR Coagulation Kit is a convenience kit that contains three levels of control material that can be used to verify the analytical measurement range of the eight different assays. | George King AMR Coagulation Kit | GEORGE KING BIO-MEDICAL, INC | |
| 36 | 00815696020429 | 4000 - 1.5 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay. | George King Coumadin® Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 37 | 00815696020412 | 0040-1.0 | George King B-FACT is a borderline abnormal fresh frozen citrated control that i George King B-FACT is a borderline abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King B-FACT | GEORGE KING BIO-MEDICAL, INC | |
| 38 | 00815696020405 | 0040-0.5 | George King B-FACT is a borderline normal fresh frozen citrated control that is George King B-FACT is a borderline normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King B-FACT | GEORGE KING BIO-MEDICAL, INC | |
| 39 | 00815696020399 | 0030-1.0 | George King A-FACT is a low abnormal fresh frozen citrated control that is used George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King A-FACT | GEORGE KING BIO-MEDICAL, INC | |
| 40 | 00815696020382 | 0030-0.5 | George King A-FACT is a low abnormal fresh frozen citrated control that is used George King A-FACT is a low abnormal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King A-FACT | GEORGE KING BIO-MEDICAL, INC | |
| 41 | 00815696020375 | 0020-1.0 | George King FACT is a normal fresh frozen citrated control that is used to verif George King FACT is a normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King FACT | GEORGE KING BIO-MEDICAL, INC | |
| 42 | 00815696020368 | 0020-0.5 | George King FACT is a normal fresh frozen citrated control that is used to verif George King FACT is a normal fresh frozen citrated control that is used to verify the performance of an assay intended to be used for the quantitative determination of multiple coagulation factors, intermediates and/or activated components. | George King FACT | GEORGE KING BIO-MEDICAL, INC | |
| 43 | 00815696020290 | 0010-250.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma and is i George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 44 | 00815696020283 | 0010-200.0 | George King Pooled Normal Plasma is fresh frozen human citrated plasma and is in George King Pooled Normal Plasma is fresh frozen human citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 45 | 00815696020276 | 0010-100.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma is intend George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 46 | 00815696020245 | 0010-50.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 47 | 00815696020160 | 0001-bulk | George King Single Donor Normal Plasma is fresh frozen human citrated plasma and George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 48 | 00815696020153 | 0001-1.0 | George King Single Donor Normal Plasma is fresh frozen citrated human plasma and George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. | George King Single Donor Normal Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 49 | 00815696020146 | 4000 - 1.0 | George King Coumadin® Plasma is citrated fresh frozen human plasma derived from George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay. | George King Coumadin® Plasma | GEORGE KING BIO-MEDICAL, INC | |
| 50 | 00815696020139 | 0010-5.0 | George King Pooled Normal Plasma is fresh frozen citrated human plasma and is in George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT. | George King Pooled Normal Plasma | GEORGE KING BIO-MEDICAL, INC |