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 | 00817643020223 | 34265 | 34265 | A1CNow+ and 20-Test Kit | Hopkins Medical Products® | HOPKINS UNIFORM COMPANY |
2 | 00817302022179 | 7-H7541-CAL | 7-H7541-CAL | HbA1c (Hemoglobin A1c) calibrator | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL | CAROLINA LIQUID CHEMISTRIES CORPORATION |
3 | 00817302022162 | 7-H7541-CTL | 7-H7541-CTL | HbA1c (Hemoglobin A1c) control | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CTL SET PART# 7-H7541-CTL | CAROLINA LIQUID CHEMISTRIES CORPORATION |
4 | 00817302022155 | BL300 | BL300 | HbA1c (Hemoglobin A1c Direct) 2 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT BL-300 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
5 | 00817302022148 | ST300 | ST300 | HbA1c 2 x 150 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HbA1c RGT KIT Pt No. ST300 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
6 | 00817302022131 | CC612 | CC612 | FRUC (Fructosamine) w/ cal 2 x 40 tests | CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
7 | 00817302022124 | AU-612 | AU-612 | FRUC (Fructosamine) w/ cal 3 x 80 tests | CAROLINA LIQUID CHEMISTRIES CORP.® FRUC RGT. KIT AU-612 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
8 | 00817302022117 | CC030 | CC030 | FRUC (Fructosamine) Control | CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
9 | 00817302020083 | CC300 | CC300 | HbA1c (Hemoglobin A1c) w/ lysis buffer 2 x 90 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c REAGENT CC300 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
10 | 00817302020076 | AU-300 | AU-300 | HbA1c (Hemoglobin A1c Direct) 1 x 200 tests | CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c RGT. KIT AU-300 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
11 | 00817274021774 | XL-A1C2-30 | HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
12 | 00817274021767 | A1C2-30 | HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b) | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
13 | 00817274021750 | A1C2-30A | HEMOGLOBIN A1C REAGENT (1x 30mL R1, 1x 9.5mL R2a, 1x 0.5mL R2b | JAS Diagnostics | DREW SCIENTIFIC, INC. | |
14 | 00817274020593 | 014-081 | Gold Column Kit | Drew Scientific | DREW SCIENTIFIC, INC. | |
15 | 00817274020524 | DSJ-9001-021 | DS360 HbA1c Analyzer (Instrument only) | Drew | DREW SCIENTIFIC, INC. | |
16 | 00817274020517 | DSJ-9001-001 | DS360 HbA1c Analyzer with accessories | Drew Scientific | DREW SCIENTIFIC, INC. | |
17 | 00817274020241 | 099-024 | DS360 Column (1,000-Test) | Drew | DREW SCIENTIFIC, INC. | |
18 | 00817274020234 | 099-023 | DS360 Reagent Test Kit (500 tests) | Drew Scientific | DREW SCIENTIFIC, INC. | |
19 | 00817274020173 | 014-350 | DS5 Pink Kit (300 test) | Drew Scientific | DREW SCIENTIFIC, INC. | |
20 | 00817274020135 | 014-080 | Gold Kit 80-100 Test | Drew Scientific | DREW SCIENTIFIC, INC. | |
21 | 00817238011322 | 85621 | Hemoglobin A1C Reagent | Hemoglobin A1C Reagent | CLINIQA CORPORATION | |
22 | 00816426020788 | K29C-4M | K29C-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 hemoglobin A1c. | K-ASSAY® Hemoglobin A1c Control | KAMIYA BIOMEDICAL COMPANY, LLC |
23 | 00816426020696 | KAI-098C | KAI-098C | For the calibration of the K-ASSAY® Hemoglobin A1c assay. | K-ASSAY® Hemoglobin A1c Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC |
24 | 00816426020597 | KAI-048C | KAI-048C | For the calibration of the K-ASSAY® Fructosamine assay. | K-ASSAY® Fructosamine Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC |
25 | 00816426020528 | KAI-197 | KAI-197 | For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood. | K-ASSAY® Hemoglobin A1c Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC |
26 | 00816426020511 | KAI-196 | KAI-196 | For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood. | K-ASSAY® Hemoglobin A1c Reagent | KAMIYA BIOMEDICAL COMPANY, LLC |
27 | 00816426020504 | KAI-195 | KAI-195 | Hemolysis reagent for hemoglobin A1c (HbA1c) measurement. | K-ASSAY® Hemoglobin A1c Hemolysis Reagent | KAMIYA BIOMEDICAL COMPANY, LLC |
28 | 00816426020269 | KAI-050 | KAI-050 | For the quantitative determination of fructosamine in serum. | K-ASSAY® Fructosamine Reagent + Calibrator (L) | KAMIYA BIOMEDICAL COMPANY, LLC |
29 | 00816426020238 | KAI-043 | KAI-043 | For the quantitative determination of fructosamine in serum. | K-ASSAY® Fructosamine Reagent + Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 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. |
34 | 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. |
35 | 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. |
36 | 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. |
37 | 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. |
38 | 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. |
39 | 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. |
40 | 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. |
41 | 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. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 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. |
46 | 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. |
47 | 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. |
48 | 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. |
49 | 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. |
50 | 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. |