| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10873037000766 | X00-003808-001 | X00-003808-001 | CritSpin Digital Reader | JPI | Device, Hematocrit Measuring | 2 | StatSpin |
| 2 | 10873037000216 | X00-004998-001 | X00-004998-001 | StatSpin MP Multipurpose Centrifuge | JPI | Device, Hematocrit Measuring | 2 | StatSpin |
| 3 | 10837461008002 | Specific Gravity Calibrator Set (NA) | 800-3517 | AX-4280 Specific Gravity Calibrator Set | KQO | Automated Urinalysis System | 1 | AX-4280 |
| 4 | 10837461002710 | CalChek Kit | 800-7703 | iChem® VELOCITY™ CalChek Kit | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | iChem® VELOCITY™ |
| 5 | 10837461002642 | Wash Solution Case of 2 x 7 L | 800-7217 | iChem® VELOCITY™ Wash Solution Case of 2 x 7 L | PPM | General Purpose Reagent | iChem® VELOCITY™ | |
| 6 | 10837461002628 | iChem VELOCITY Urine Chemistry Strips | 800-7212 | iChem VELOCITY Urine Chemistry Strips | JJB,JIR,JIN,JMA,LJX,JRE,JMT,CEN,CDM,JIO,KQO,JIL | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.),Indicat Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.),Indicator Method, Protein Or Albumin (Urinary, Non-Quant.),Nitroprusside, Ketones (Urinary, Non-Quant.),Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric),Test, Urine Leukocyte,Refractometer For Clinical Use,Diazo (Colorimetric), Nitrite (Urinary, Non-Quant),Dye-Indicator, Ph (Urinary, Non-Quant.),Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.),Blood, Occult, Colorimetric, In Urine,Automated Urinalysis System,Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | iChem® VELOCITY™ |
| 7 | 10837461002529 | iChem®10SG Urine Chemistry Strips | 800-7005 | iChem®10 SG Urine Chemistry Strips | KQO,LJX,JJQ,CDM,JIR,CEN,JMT,JIN,JJB,JMA,JIO,JIL | Automated Urinalysis System,Test, Urine Leukocyte,Colorimeter, Photometer, Spect Automated Urinalysis System,Test, Urine Leukocyte,Colorimeter, Photometer, Spectrophotometer For Clinical Use,Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.),Indicator Method, Protein Or Albumin (Urinary, Non-Quant.),Dye-Indicator, Ph (Urinary, Non-Quant.),Diazo (Colorimetric), Nitrite (Urinary, Non-Quant),Nitroprusside, Ketones (Urinary, Non-Quant.),Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.),Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric),Blood, Occult, Colorimetric, In Urine,Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 | iChem |
| 8 | 10837461002475 | Body Fluids Module | 800-3704 | iQ®200 Body Fluids Module (CD only) | GKL | Counter, Cell, Automated (Particle Counter) | 2 | iQ®200 |
| 9 | 10837461002376 | iQ® Lamina™ Case of 2 x 7 L | 800-3236 | iQ® Lamina™ Case of 2 x 7 L | PPM | General Purpose Reagent | iQ®200 | |
| 10 | 10837461002345 | iQ® Body Fluids Controls-Level I and Level II (NA/INTL) | 800-3219 | iQ® Body Fluids Controls-Level I and Level II (NA/INTL) | JPK | Mixture, Hematology Quality Control | 2 | iQ®200 |
| 11 | 10837461002307 | iQ® Body Fluids Lysing Reagent (NA/INTL) | 800-3213 | iQ® Body Fluids Lysing Reagent (NA/INTL) | PPM | General Purpose Reagent | 1 | iQ®200 |
| 12 | 10837461002192 | iQ® Lamina™ Cradle | 800-3105 | iQ® Lamina™ Cradle | LKM | Counter, Urine Particle | 2 | iQ®200 |
| 13 | 10837461002178 | iQ® Control/Focus Set (NA/INTL) | 800-3104 | iQ® Control/Focus Set (NA/INTL) | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | iQ®200 |
| 14 | 10837461002147 | iQ® Calibrator | 800-3103 | iQ® Calibrator Pack | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | iQ®200 |
| 15 | 10837461002116 | iQ® Lamina™ Case of 4 x 7 L | 800-3102 | PPM | General Purpose Reagent | 1 | iQ®200 | |
| 16 | 10837461002680 | CA/CB/CC URINE CHEMSITRY CONTROLS | 800-7702 | IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | IRISpec |
| 17 | 10837461002611 | CA/CB/CC URINE CHEMSITRY CONTROLS | 800-7211 | IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | IRISpec |
| 18 | 10837461001973 | CA/CB Twinset | 800-7211 | IRISpec CA/CB Twinset | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | IRISpec |
| 19 | 10837461001355 | Elite Plus (US) (2008 Version) (NA) | 700-3375 | "iQ200 Elite 2008 Tested;800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA);800 "iQ200 Elite 2008 Tested;800-3934 iQ®200 Elite Plus (US) (2008 Version) (NA);800-7714 IRICELL 2000 Plus (NA)" | KQO,LKM | Automated Urinalysis System,Counter, Urine Particle | 1 | iQ200 |
| 20 | 10837461001317 | Select/Elite Pro (NA) | 700-3347/700-3375 | "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)""iQ200 Elite 2008 Test "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)""iQ200 Elite 2008 Tested; 800-3052 iQ®200 Elite Pro (NA); 800-3049 IRICELL 2000 Pro (NA)" | KQO,LKM | Automated Urinalysis System,Counter, Urine Particle | 1 | iQ200 |
| 21 | 10837461001300 | Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA) | 700-3345 | "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA)"iQ2 "iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA)"iQ200 Select 2008 Tested; 800-3051 iQ®200 Select Pro (NA); 800-3050 IRICELL 1000 Pro (NA); 800-3048 IRICELL 3000 Pro (NA)" | KQO,LKM | Automated Urinalysis System,Counter, Urine Particle | 1 | iQ200 |
| 22 | 10837461001256 | Sprint Pro (NA)/SPRINT w load/unload (NA)/SPRINT Pro w load/unload (NA)/Sprint P | 700-3325 | "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)""iQ200 Sprint 2008 Te "iQ200 Sprint 2008 Tested; 800-3053 iQ®200 Sprint Pro (NA)""iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA);""iQ200 Sprint 2008 Tested; 800-3082 iQ200 SPRINT Pro w load/unload (NA); 800-3080 IRICELL 3000 PRO w load/unload; 800-3048 IRICELL 3000 Pro (NA)""iQ200 Sprint 2008 Tested; 800-3933 iQ®200 Sprint Plus US (2008 Version) (NA); 800-7713 IRICELL 3000 Plus (NA);800-3079 IRICELL 3000 Plus w/ Load Unload (NA)" | KQO,LKM | Automated Urinalysis System,Counter, Urine Particle | 1 | iQ200 |
| 23 | 10837461002536 | vChem®10 SG Urine Chemistry Strips | 800-7007 | vChem®10 SG Urine Chemistry Strips | JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 2 | vChem® |
| 24 | 10837461009375 | Elite/Stand-Alone Velocity (NA) | 700-7176-001 | "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automa "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automated Urine Chemistry System w load/Unload (NA)""2.5 iChem Velocity Instrument Bring Up and Test; 800-7719 Stand-Alone Velocity (NA)" | KQO | Automated Urinalysis System | 1 | iChem Velocity |
| 25 | 10837461002260 | System Cleanser (NA/INTL) | 800-3203 | Iris® System Cleanser Pack (NA/INTL) | PPM | General Purpose Reagent | 1 | Iris® |
| 26 | 10837461002239 | Diluent (NA) | 800-3202 | Iris® Diluent Pack (NA) | GIF | Diluent, Blood Cell | 1 | Iris® |
| 27 | 10837461001751 | Back-Integrated Velocity (NA) | 700-7177-001 | 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Inte 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA)2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)" | KQO | Automated Urinalysis System | 1 | iChem Velocity |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 30858512007137 | 323-17-12 | 323-17-12 | Liquid Urine Control - Level 1/Level 2, 25 ml. Contains 3 vials Level 1 and 3 vi Liquid Urine Control - Level 1/Level 2, 25 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 2 | 30858512007106 | 323-16-12 | 323-16-12 | Liquid Urine Control - Level 1/Level 2, 10 ml. Contains 3 vials Level 1 and 3 vi Liquid Urine Control - Level 1/Level 2, 10 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 3 | 30858512007052 | 303-12 | 303-12 | Liquid Urine Control Dipstick - Negative/Positive. Contains 2 vials Negative and Liquid Urine Control Dipstick - Negative/Positive. Contains 2 vials Negative and 2 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 4 | 30858512007021 | 301-12 | 301-12 | Liquid Urine Control Dipstick - Negative/Positive, 20 ml. Contains 3 vials Negat Liquid Urine Control Dipstick - Negative/Positive, 20 ml. Contains 3 vials Negative and 3 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 5 | 20612479214969 | 163-89123 | Premium Liquid Urine BOTTLE STYLE WITH MICROSCOPICS | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 6 | 20612479214952 | 163-89228 | Premium Liquid Urine DIPTUBE STYLE WITH MICROSCOPICS | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 7 | 20612479214945 | 163-89116 | Premium Liquid Urine Controls DROPPER STYLE | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 8 | 20612479214938 | 163-89119 | Premium Liquid Urine Controls DROPPER STYLE | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 9 | 10885380151934 | CHUA260 | CHUA260 | UA Control Bottle Abnormal -240mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 10 | 10885380151927 | CHUA215 | CHUA215 | UA Control Tube Abnormal -90mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 11 | 10885380151910 | CHUA160 | CHUA160 | UA Control Bottle Normal -240mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 12 | 10885380151903 | CHUA115 | CHUA115 | UA Control Tube Normal -90mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 13 | 10885380151897 | CH1470-01 | CH1470-01 | UA Control Bottle Set -480mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 14 | 10885380151880 | CH1440-04 | CH1440-04 | UA Control Dropper Bottle Set -50mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 15 | 10885380151873 | CH1440-02 | CH1440-02 | UA Control Dropper Bottle Set-100mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 16 | 10885380151866 | CH1440-01 | CH1440-01 | UA Control Tube Set -90mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 17 | 10858512007126 | 323-17-2 | 323-17-2 | Liquid Urine Control - Level 2, 25 ml. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 18 | 10858512007119 | 323-17-1 | 323-17-1 | Liquid Urine Control - Level 1, 25 ml. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 19 | 10858512007096 | 323-16-2 | 323-16-2 | Liquid Urine Control - Level 2, 10 ml. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 20 | 10858512007089 | 323-16-1 | 323-16-1 | Liquid Urine Control - Level 1, 10 ml. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 21 | 10858512007072 | 301-4 | 301-4 | Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 m Liquid Urine Control for Microscopic and High Specific Gravity - Negative, 250 ml. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 22 | 10858512007065 | 301-3 | 301-3 | Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 m Liquid Urine Control for Microscopic and High Specific Gravity - Positive, 250 ml. 18 month open vial stability when stored at 2-8° C. Contains Polystyrene and Latex. | NA | ALTA DIAGNOSTICS INC |
| 23 | 10858512007041 | 303-2 | 303-2 | Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Positive, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 24 | 10858512007034 | 303-1 | 303-1 | Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Negative, 30 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 25 | 10858512007010 | 301-2 | 301-2 | Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Positive, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 26 | 10858512007003 | 301-1 | 301-1 | Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at r Liquid Urine Control Dipstick - Negative, 20 ml. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C. | NA | ALTA DIAGNOSTICS INC |
| 27 | 10837461002710 | CalChek Kit | 800-7703 | iChem® VELOCITY™ CalChek Kit | iChem® VELOCITY™ | IRIS INTERNATIONAL, INC. |
| 28 | 10837461002680 | CA/CB/CC URINE CHEMSITRY CONTROLS | 800-7702 | IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS | IRISpec | IRIS INTERNATIONAL, INC. |
| 29 | 10837461002611 | CA/CB/CC URINE CHEMSITRY CONTROLS | 800-7211 | IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS | IRISpec | IRIS INTERNATIONAL, INC. |
| 30 | 10837461002178 | iQ® Control/Focus Set (NA/INTL) | 800-3104 | iQ® Control/Focus Set (NA/INTL) | iQ®200 | IRIS INTERNATIONAL, INC. |
| 31 | 10837461002147 | iQ® Calibrator | 800-3103 | iQ® Calibrator Pack | iQ®200 | IRIS INTERNATIONAL, INC. |
| 32 | 10837461002031 | iQ Precision Kit | 800-3014 | iQ Precision Kit | iQ®200 | IRIS INTERNATIONAL, INC. |
| 33 | 10837461001973 | CA/CB Twinset | 800-7211 | IRISpec CA/CB Twinset | IRISpec | IRIS INTERNATIONAL, INC. |
| 34 | 10612479197494 | 121-MAC | URINE TEST STRIP, MICRO ALBUMI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 35 | 05391516743204 | O6627 | O6627 | Oxalate Urine Control - N | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 36 | 05391516743198 | O6502 | O6502 | Oxalate Urine Control - E | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 37 | 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 | |
| 38 | 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 | |
| 39 | 05055273200546 | AU2353 | AU2353 | ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3) | RANDOX LABORATORIES LIMITED | |
| 40 | 05055273200539 | AU2352 | AU2352 | ASSAYED URINE CONTROL - LEVEL 2 (URN ASY CONTROL 2) | RANDOX LABORATORIES LIMITED | |
| 41 | 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. | |
| 42 | 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. | |
| 43 | 04250317546593 | 0373 | 0373 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 44 | 04250317546586 | 0372 | 0372 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 45 | 04250317546579 | 0381 | 0381 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 46 | 04250317546562 | 0382 | 0382 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 47 | 04250317546531 | 0377 | 0377 | MassCheck® total Metanephrines, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 48 | 04250317546524 | 0376 | 0376 | MassCheck® total Metanephrines, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 49 | 04250317545138 | 0140 | 0140 | Urine Control Level II o-Cresol, p-Cresol, Phenol in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 50 | 04250317545121 | 0139 | 0139 | Urine Control Level I, o-Cresol, p-Cresol, Phenol in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |