| 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 | 05391516743204 | O6627 | O6627 | Oxalate Urine Control - N | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 2 | 05391516743198 | O6502 | O6502 | Oxalate Urine Control - E | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 3 | 05055273207590 | UC5034 | This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of urine test strips. | URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2) | RANDOX LABORATORIES LIMITED | |
| 4 | 05055273207583 | UC5033 | This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of urine test strips. | URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1) | RANDOX LABORATORIES LIMITED | |
| 5 | 05055273200546 | AU2353 | AU2353 | ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3) | RANDOX LABORATORIES LIMITED | |
| 6 | 05055273200539 | AU2352 | AU2352 | ASSAYED URINE CONTROL - LEVEL 2 (URN ASY CONTROL 2) | RANDOX LABORATORIES LIMITED | |
| 7 | 04987486738060 | 73806 | Aution AU Control Solution is supplied in 2 different levels (High and Low) and Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) | Aution™ AU Control Solution | ARKRAY USA, INC. | |
| 8 | 04987486009801 | 102478 | Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL o Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.) | AUTION Check Plus Controls | ARKRAY USA, INC. | |
| 9 | 04250317546593 | 0373 | 0373 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 10 | 04250317546586 | 0372 | 0372 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 11 | 04250317546579 | 0381 | 0381 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 12 | 04250317546562 | 0382 | 0382 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 13 | 04250317546531 | 0377 | 0377 | MassCheck® total Metanephrines, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 14 | 04250317546524 | 0376 | 0376 | MassCheck® total Metanephrines, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 15 | 04250317545138 | 0140 | 0140 | Urine Control Level II o-Cresol, p-Cresol, Phenol in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 16 | 04250317545121 | 0139 | 0139 | Urine Control Level I, o-Cresol, p-Cresol, Phenol in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 17 | 04250317544919 | 0163 | 0163 | Urine Control Level II, t,t-Muconic acid in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 18 | 04250317544902 | 0162 | 0162 | Urine Control Level I, t,t-Muconic acid in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 19 | 04250317543790 | 0050 | 0050 | Endocrine urine control, pathological range | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 20 | 04250317543660 | 0040 | 0040 | Endocrine urine control, normal range | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 21 | 04250317542847 | 0146 | 0146 | Urine Control Level II, Porphyrins in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 22 | 04250317542830 | 0145 | 0145 | Urine Control Level I, Porphyrins in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 23 | 04250317542779 | 0143 | 0143 | Urine Control Level II, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Ac Urine Control Level II, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 24 | 04250317542762 | 0142 | 0142 | Urine Control Level I, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Ac Urine Control Level I, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 25 | 04250317502148 | 0161 | 0161 | Urine Control Bi-Level, t,t-Muconic acid in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 26 | 04250317501271 | 0144 | 0144 | Urine Control Bi-Level, Porphyrins in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 27 | 04250317501226 | 0141 | 0141 | Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic A Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 28 | 04250317501127 | 0138 | 0138 | Urine Control Bi-Level, o-Cresol, p-Cresol, Phenol in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 29 | 03610522007998 | 12007029 | 12007029 | qUAntify Advance Control Bilevel MiniPak (A liquid urinalysis control.) | qUAntify | BIO-RAD LABORATORIES, INC. |
| 30 | 03610522007981 | 12007028 | 12007028 | qUAntify Advance Control Bilevel (A liquid urinalysis control.) | qUAntify | BIO-RAD LABORATORIES, INC. |
| 31 | 00896863002387 | 1400-02 | 1400-02 | The Dipper POCT is a two level urinalysis dipstick control. Each level is contai The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert. | Dipper POCT Level 1&2 Set 20x1.5mL | QUANTIMETRIX CORPORATION |
| 32 | 00896863002370 | 1400-01 | 1400-01 | The Dipper POCT is a two level urinalysis dipstick control. Each level is contai The Dipper POCT is a two level urinalysis dipstick control. Each level is contained in a single-use plastic pouch filled with 1.5mL of liquid control material that is ready-to-use, requiring no reconstitution of dilution. The controls are formulated from a simulated urine matrix fortified with preservatives and stabilizers to maintain product integrity and inhibit microbial growth. Each control level is formulated to target levels with compounds that produce the desired reaction when tested by methods indicated in the product insert. | Dipper POCT Level 1&2 Set 62x1.5mL | QUANTIMETRIX CORPORATION |
| 33 | 00896863002226 | 1432-32 | 1432-32 | The Dropper Urine Chemistry Control is intended for use as a control for human u The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Urine Chemistry Control Level 2 Set 3x25mL | QUANTIMETRIX CORPORATION |
| 34 | 00896863002219 | 1432-31 | 1432-31 | The Dropper Urine Chemistry Control is intended for use as a control for human u The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Urine Chemistry Control Level 2 Set 3x10mL | QUANTIMETRIX CORPORATION |
| 35 | 00896863002202 | 1431-32 | 1431-32 | The Dropper Urine Chemistry Control is intended for use as a control for human u The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Urine Chemistry Control Level 1 Set 3x25mL | QUANTIMETRIX CORPORATION |
| 36 | 00896863002196 | 1431-31 | 1431-31 | The Dropper Urine Chemistry Control is intended for use as a control for human u The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Urine Chemistry Control Level 1 Set 3x10mL | QUANTIMETRIX CORPORATION |
| 37 | 00896863002189 | 1430-01 | 1430-01 | The Dropper Urine Chemistry Control is intended for use as a control for human u The Dropper Urine Chemistry Control is intended for use as a control for human urine assay methods. It is supplied as a ready-to-use liquid requiring no reconstitution. They are prepared from human urine and fortified to target levels with human proteins and reagent grade chemicals. Preservatives have been added to inhibit microbial growth. | Dropper Urine Chemistry Control Level 1&2 Set 2x10mL | QUANTIMETRIX CORPORATION |
| 38 | 00896863002165 | 1440-06 | 1440-06 | The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a cont The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels, liquid, ready-to-use, requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 2x5mL | QUANTIMETRIX CORPORATION |
| 39 | 00896863002158 | 1440-04 | 1440-04 | The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a cont The Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels, liquid, ready-to-use, requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Dropper Plus Point-of-Care Urinalysis Dipstick Control Level 1&2 Set 10x5mL | QUANTIMETRIX CORPORATION |
| 40 | 00896863002141 | 1442-61 | 1442-61 | The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis r The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Dipper Urinalysis Dipstick Control Level 2 Set 6x15mL | QUANTIMETRIX CORPORATION |
| 41 | 00896863002134 | 1440-01 | 1440-01 | The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis r The Dipper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are supplied in two levels as 6x15mL, three tubes of each level or 6x15mL level 2 only. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL | QUANTIMETRIX CORPORATION |
| 42 | 00896863002127 | 1440-03 | 1440-03 | The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Dropper Urinalysis Dipstick Control Level 1&2 Set 2x25mL | QUANTIMETRIX CORPORATION |
| 43 | 00896863002110 | 1440-02 | 1440-02 | The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis The Dropper Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests. They are liquid, ready-to-use requiring no reconstitution or dilution. They are prepared from human urine fortified to target levels with compounds that produce the desired reaction when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Dropper Urinalysis Dipstick Control Level 1&2 Set 4x25mL | QUANTIMETRIX CORPORATION |
| 44 | 00896863002103 | 1250-01 | 1250-01 | The Microbumin Microalbumin Control is intended as a means of monitoring various The Microbumin Microalbumin Control is intended as a means of monitoring various microalbumin assay methods to validate quantitation of patient samples. It is supplied in two levels, 5x7mL each level per box. They are ready-to-use, liquid, requiring no reconstitution. They are prepared from human urine, fortified to target levels with human albumin and creatinine. Preservatives have been added to inhibit microbial growth. | Microbumin Microalbumin Control Level 1&2 Set 10x7mL | QUANTIMETRIX CORPORATION |
| 45 | 00896863002042 | 1540-02 | 1540-02 | The Chromascopics Urinalysis Control with Microscopics is intended as an assayed The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemistry Analyzer. It is also compatible with Siemens urinalysis dipsticks and Clinitek analyzers, confirmatory tests, and qualitative methods. It may also be used as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. It is supplied as a liquid, ready-to-use control in two levels, configured with 2x120mL of each level per box. It does not required reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, non-pathogenic bacteria, and other compounds have been added to produce desired reactions when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Chromascopics Control Level 1&2 Set 4x120mL (Domestic) | QUANTIMETRIX CORPORATION |
| 46 | 00896863002035 | 1540-01 | 1540-01 | The Chromascopics Urinalysis Control with Microscopics is intended as an assayed The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus Automated Urine Chemistry Analyzer and Atellica 800 and 1500 systems. It is also compatible with Siemens urinalysis dipsticks, confirmatory tests, and qualitative methods. It may also be used as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment. It is supplied as a liquid, ready-to-use control in two levels, configured with 2x120mL of each level per box. It does not required reconstitution or dilution. They are prepared from human urine to which stabilized human red and white blood cells, calcium oxalate crystals, non-pathogenic bacteria, and other compounds have been added to produce desired reactions when tested by the methods indicated in the product insert. Preservatives have been added to inhibit microbial growth. | Chromascopics Control Level 1&2 Set 4x120mL (International) | QUANTIMETRIX CORPORATION |
| 47 | 00884883004405 | 10014127 | MAS® UrichemTRAK Liquid Assayed Urine Control | MICROGENICS CORPORATION | ||
| 48 | 00884883004160 | 024227 | MAS Urinalysis Liquid Urinalysis Control 3 | MICROGENICS CORPORATION | ||
| 49 | 00884883004153 | 024224 | MAS Urinalysis Liquid Urinalysis Control 3 | MICROGENICS CORPORATION | ||
| 50 | 00884883004146 | 024225 | MAS Urinalysis Liquid Urinalysis Control 1 | MICROGENICS CORPORATION |