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 | 00812137012203 | 4 x 0.5mL | 502-189 | This product is for the purpose of calibrating results in the quantitative deter This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. | HbA1c Calibrator Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
2 | 00812137012166 | L1 x 2 x 0.5mL, L2 x 2 x 0.5mL | 502-156 | This product is for the purpose of monitoring accuracy and precision in the quan This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period. | HbA1c Control Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
3 | 00812137012081 | R1 x 30mL, R2 x 10mL, R3 x 125mL | 501-421 | For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | HbA1c Reagent Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
4 | 00811727016164 | 16-H7546-200 | 16-H7546-200 | Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 1 Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 10ml R2. For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | Pointe HbA1c Reagent | POINTE SCIENTIFIC, INC. |
5 | 00811727015853 | 14-H7546-160 | 14-H7546-160 | Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the Pointe HbA1c Reagent packaged for use on the BS480. 2x60mL, 2x20mL Kit. For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | Pointe HbA1c for the BS480 | POINTE SCIENTIFIC, INC. |
6 | 00811727015044 | OH546-40 | OH546-40 | Pointe Scientific, Inc. HbA1c Reagent is for the quantitative determination of H Pointe Scientific, Inc. HbA1c Reagent is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Packaged for use on Olympus Analyzers. For in vitro diagnostic use only. 2 x 15ml, 1 x 10ml | Pointe Scientific, Inc. HbA1c | POINTE SCIENTIFIC, INC. |
7 | 00811727014559 | H7546-CAL | H7546-CAL | Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibra Liquid Hemoglobin A1c Calibrator Set, This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Size: 4 x 1 mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
8 | 00811727014542 | H7546-120 | H7546-120 | Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (Hb Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Size: 1 x 90 mL, 1 x 30 mL | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
9 | 00811727014535 | H7546-40 | H7546-40 | Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (Hb Hemoglobin A1c Reagent, for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. Size: 1 x 30 mL, 1 x 10 mL. | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
10 | 00811727014245 | 13-G7540-STD | 13-G7540-STD | This product is for the purpose of standardizing results obtained from run to ru This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1 ml | Pointe Scientific, Inc. Glyco Standard | POINTE SCIENTIFIC, INC. |
11 | 00811727014238 | 13-G7540-RES-120 | 13-G7540-RES-120 | Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.1 x 120 ml | Pointe Scientific, Inc. Glyco Resin | POINTE SCIENTIFIC, INC. |
12 | 00811727014221 | 13-G7540-LYS-30 | 13-G7540-LYS-30 | Lyse for the quantitative determination of Glycohemoglobin (HbA1) in blood by ca Lyse for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.1 x 30 ml | Pointe Scientific, Inc. Gyco Lyse | POINTE SCIENTIFIC, INC. |
13 | 00811727013569 | 12-H7546-40 | 12-H7546-40 | For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | HbA1c | POINTE SCIENTIFIC, INC. |
14 | 00811727013545 | 12-H7541-40 | 12-H7541-40 | For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. | HbA1c | POINTE SCIENTIFIC, INC. |
15 | 00811727013521 | 12-F7546-55 | 12-F7546-55 | This reagent is intended for the quantitative determination of fructosamine in h This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only. | Fructosamine | POINTE SCIENTIFIC, INC. |
16 | 00811727011541 | H7541-CTL | H7541-CTL | This product is for the purpose of monitoring accuracy and precision in the quan This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
17 | 00811727011534 | H7541-CAL | H7541-CAL | This product is for the purpose of calibrating results in the quantitative deter This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
18 | 00811727011510 | H7541-120 | H7541-120 | Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. 1 x 90ml, 1 x 28.5ml, 1 x 1.5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
19 | 00811727011503 | H7541-40 | H7541-40 | Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human bl Reagent for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. 1 x 30ml, 1 x 9.5ml, 1 x .5ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
20 | 00811727011336 | G7540-2 | G7540-2 | Controls for use in the quantitative determination of human glycohemoglobin (HbA Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.2 x 1.0ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
21 | 00811727011329 | G7540-STD | G7540-STD | This product is for the purpose of standardizing results obtained from run to ru This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin.1 x 1.0ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
22 | 00811727011312 | G7540-80 | G7540-80 | Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by ca Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.80 test | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
23 | 00811727011305 | G7540-40 | G7540-40 | Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by ca Test for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus.40 test | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
24 | 00811727011091 | F7546-CTL | F7546-CTL | These Fructosamine Controls are intended for use in fructosamine test systems to These Fructosamine Controls are intended for use in fructosamine test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.1 For in vitro diagnostic use only. | POINTE SCIENTIFIC Fructosamine Control Set | POINTE SCIENTIFIC, INC. |
25 | 00811727011084 | F7546-CAL | F7546-CAL | The Fructosamine calibrator is derived from pooled human serum containing buffer The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay. | POINTE SCIENTIFIC Fructosamine Calibrator | POINTE SCIENTIFIC, INC. |
26 | 00811727011077 | F7546-110 | F7546-110 | This reagent is intended for the quantitative determination of fructosamine in h This reagent is intended for the quantitative determination of fructosamine in human serum. For in vitro diagnostic use only. | POINTE SCIENTIFIC Fructosamine | POINTE SCIENTIFIC, INC. |
27 | 00681131403252 | 3055 | 3055 | The ReliOn A1C Self Test System provides a quantitative measurement of the perce The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary (fingerstick) blood samples. The test is for home use to monitor glycemic control in people with diabetes. | ReliOn™ 2CT A1C Meter | WAL-MART STORES, INC. |
28 | 00681131078368 | 3055 | 3055 | The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of gl The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples. | ReliOn™ Fast A1C Test | WAL-MART STORES, INC. |
29 | 00657498001523 | S0360-200 | S0360-200 | For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. | Sirrus® Direct Gylcohemoglobin (HbA1c) | STANBIO LABORATORY, L.P. |
30 | 00657498000922 | 0357-201 | 0357-201 | For Use as Human Glycohemoglobin Controls in Quantitative Glycohemoglobin Procedures. | Glycohemoglobin Bi-Level Controls | STANBIO LABORATORY, L.P. |
31 | 00657498000915 | P350-050 | P350-050 | For the Quantitative Colorimetric Determination of Glycohemoglobin in Whole Blood. | Glycohemoglobin Pre-Fil | STANBIO LABORATORY, L.P. |
32 | 00657498000908 | 0350-060 | 0350-060 | For the Quantitative Colorimetric Determination of Glycohemoglobin in Whole Blood. | Glycohemoglobin | STANBIO LABORATORY, L.P. |
33 | 00657498000892 | 0355-201 | 0355-201 | For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in h For use as controls in the Quantitative Determination of Hemoglobin (HbA1c) in human blood. | Direct Glycohemoglobin (HbA1c) Control Set | STANBIO LABORATORY, L.P. |
34 | 00657498000885 | 0365-401 | 0365-401 | For use as a calibrator in the quantitative determination of human Hemoglobin A1 For use as a calibrator in the quantitative determination of human Hemoglobin A1c (HbA1c) in blood by automated immunoassay. | Direct Glycohemoglobin (HbA1c) Calibrator Set | STANBIO LABORATORY, L.P. |
35 | 00657498000878 | 0360-040 | 0360-040 | For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. | Direct Glycohemoglobin (HbA1c) | STANBIO LABORATORY, L.P. |
36 | 00657498000847 | 2350-062 | 2350-062 | Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Stanbio Glycated Serum Protein (GSP) Assay in conjunction with Stanbio Glycated Serum Protein calibrator, are intended for the quantitative determination of glycated serum proteins (GSP; glycated albumin; fructosamine) in serum. The measurement of glycated serum proteins is useful for monitoring diabetic patients. | Glycated Serum Protein (GSP) LiquiColor® | STANBIO LABORATORY, L.P. |
37 | 00630414977485 | 10487396 | LCOCVM | Cortisol Sample Diluent CVM - IMMULITE - CONS | IMMULITE® Systems COR Calibration Verification Material Cortisol | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
38 | 00630414596129 | 11097500 | 11097500 | Hemoglobin A1c_3 (A1c_3) Atellica CH - RGT 400T | Atellica CH A1c_3 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 00630414595580 | 11097637 | 11097637 | Fructosamie (Fruc) Atellica CH - RGT 400T | Atellica CH Fruc | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
40 | 00630414571270 | 10485591 | 10485591 | HbA1c - ADVIA Chem. - RGT - 4x200 tests | ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
41 | 00630414569512 | 10379673 | 10379673 | HbA1c - ADVIA Chem. - RGT - 2x80 tests | ADVIA® Chemistry A1c_3 Hemoglobin A1c Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
42 | 00630414558080 | 10361942 | 4862528 | Lipoprotein - ADVIA Chem. - RGT - 200 tests | ADVIA® Chemistry LP(A) Lipoprotein(a) Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00630414558073 | 10361941 | 4862501 | Fructosamine - ADVIA Chem. - RGT - 200 tests | ADVIA® Chemistry FRUC Reagents | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
44 | 00630414555140 | 10286032 | 4795367 | HbA1C Denaturant - ADVIA Chem. - CONS - 920mL (for 920 Tests) | ADVIA® Chemistry HbA1c Denaturant Reagent - Manual Pretreat | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
45 | 00630414551364 | 10282969 | 5075US | The DCA Vantage system is a semi-automated, benchtop system. It is designed to q The DCA Vantage system is a semi-automated, benchtop system. It is designed to quantitatively measure the percent of Hemoglobin A1cin blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The DCA Vantage system is intended for professional use in a physician’s office or hospital laboratory. Tests performed usingthe DCA Vantage system are intended for in vitro diagnostic use. | DCA Vantage® Analyzer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00630414532806 | 10311134 | 5035C | DCA HbA1c Test Kit (monitoring only) - INTL. | DCA™ Systems Hemoglobin A1c Reagent Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00630414497105 | 10311161 | 5068A | The DCA™ Hemoglobin A1c Control Kit contains both NORMAL Controls and ABNORMAL C The DCA™ Hemoglobin A1c Control Kit contains both NORMAL Controls and ABNORMAL Controls which are prepared as a stabilized hemolysate from human blood. The DCA Hemoglobin A1c Control Kit has been designed for use with DCA™ Analyzers. | DCA™ Systems Hemoglobin A1c Control Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00630414220505 | 11097536 | 11097536 | Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH - RGT 600T | Atellica CH A1c_E | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00630414220505 | 11097536 | 11097536 | Enzymatic Hemoglobin A1c_E (A1c_E) Atellica CH - RGT 600T | Atellica CH A1c_E | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00630414171142 | 10888741 | 10888741 | A blood collection tube holder; to be used with DCA® Systems HbA1c Reagent Cartridge. | DCA® Systems Hemoglobin A1c capillary holders | SIEMENS HEALTHCARE DIAGNOSTICS INC. |