No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00884883002524 | 0017 | LAF,DKZ | Gas Chromatography, Methamphetamine,Enzyme Immunoassay, Amphetamine | 2 | DRI Amphetamines Assay | ||
2 | 00884883001442 | 100088 | DJR | Enzyme Immunoassay, Methadone | 2 | CEDIA Methadone Assay | ||
3 | 00884883012547 | 10016425 | DJR | Enzyme Immunoassay, Methadone | 2 | CEDIA Methadone Assay | ||
4 | 00884883012684 | 10017205 | ORH | Lamotrigine Assay | 2 | QMS Lamotrigine Assay | ||
5 | 00884883011854 | 10015987 | OUF | Everolimus Immunoassay | 2 | QMS Everolimus Assay | ||
6 | 00884883011625 | 10015632 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
7 | 00884883011328 | 0374116 | DLJ | Calibrators, Drug Specific | 2 | QMS Tobramycin Immunoassay Calibrator Set | ||
8 | 00884883011229 | 0373373 | LAS | Drug Specific Control Materials | 1 | QMS Zonisamide Immunoassay Control Set | ||
9 | 00884883010987 | 10014957 | DKB | Calibrators, Drug Mixture | 2 | CEDIA Multi-Drug OFT Control Set | ||
10 | 00884883007529 | 10027482 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS anti-HBs Positive Control | ||
11 | 00884883007512 | 10027481 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS HIV p24 Positive Control | ||
12 | 00884883006966 | 10023647 | QDR | Plazomicin Test System, Immunoassay | 2 | QMS Plazomicin Immunoassay | ||
13 | 00884883006959 | 969035 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix Syphilis | ||
14 | 00884883006546 | 964003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 High Control | ||
15 | 00884883006478 | 964001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 Low Control | ||
16 | 00884883006454 | 963001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HCV Low Control | ||
17 | 00884883006386 | 960041 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix GBS Positive Control | ||
18 | 00884883006027 | 963603 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix BB NAT HBV Positive Control | ||
19 | 00884883005969 | 1388 | DKB | Calibrators, Drug Mixture | 2 | DRI Negative Urine Calibrator | ||
20 | 00884883005891 | 963602 | MYZ | Kit,Test(Donors),For Bloodborne Pathogen | 2 | Acrometrix BB NAT HIV-1 POS. CTRL | ||
21 | 00884883005594 | 0920 | JXM | Enzyme Immunoassay, Benzodiazipine | 2 | DRI Benzodiazepine Serum Tox Assay | ||
22 | 00884883005587 | 0911 | DIS | Enzyme Immunoassay, Barbiturate | 2 | DRI Barbiturate Serum Tox Assay | ||
23 | 00884883005501 | 100282 | JQY | Ph Meter | 1 | DRI pH-Detect pH 3.6 Control Kit | ||
24 | 00884883005174 | 100255 | LAS | Drug Specific Control Materials | 1 | DRI Oxycodone 300 Controls | ||
25 | 00884883005082 | 100117 | DLJ | Calibrators, Drug Specific | 2 | DRI Methadone Metabolite 150 ng/mL Calibrator | ||
26 | 00884883004771 | 1732153 | DLJ | Calibrators, Drug Specific | 2 | CEDIA LSD Cutoff Calibrator | ||
27 | 00884883004399 | 10014182 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
28 | 00884883004382 | 10014181 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
29 | 00884883004375 | 10014180 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
30 | 00884883004368 | 10014179 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
31 | 00884883004337 | 1815296 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDUA DAU Opiate 2K | ||
32 | 00884883004160 | 024227 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
33 | 00884883004153 | 024224 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
34 | 00884883004108 | 1661248 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDIA DAU Opiate | ||
35 | 00884883003798 | CHU-SP | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS® ChemTRAK H Unassayed Control Sample Pack | ||
36 | 00884883003637 | LG-S1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
37 | 00884883003613 | CAI-XLS | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
38 | 00884883003606 | CAI-XL4 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
39 | 00884883003477 | 100248 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
40 | 00884883003415 | 0514 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
41 | 00884883003347 | 10013878 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
42 | 00884883003330 | 10013877 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
43 | 00884883003323 | 10013876 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
44 | 00884883002968 | 100249 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
45 | 00884883002937 | 0515 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
46 | 00884883002920 | 100116 | DJR | Enzyme Immunoassay, Methadone | 2 | DRI Methadone Metabolite Assay | ||
47 | 00884883002401 | LIG-303 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
48 | 00884883002395 | LIG-202 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
49 | 00884883002388 | LIG-101 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
50 | 00884883002371 | CAI-XLL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00612479197435 | 121-071 | CONTROL, URINE DIPPER LEV1&2 1 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
2 | 00612479197411 | 121-011 | CONTROL, URINE DROPPER LEV1&2 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
3 | 00304040004104 | 1126842 | 1126842 | Urispec Urine Dropper Control | Henry Schein | HENRY SCHEIN, INC. |
4 | 00304040004098 | 1126841 | 1126841 | Urispec Urine Dropper Control | Henry Schein | HENRY SCHEIN, INC. |
5 | 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 |
6 | 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 |
7 | 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 |
8 | 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 |
9 | 20612479214969 | 163-89123 | Premium Liquid Urine BOTTLE STYLE WITH MICROSCOPICS | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
10 | 20612479214952 | 163-89228 | Premium Liquid Urine DIPTUBE STYLE WITH MICROSCOPICS | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
11 | 20612479214945 | 163-89116 | Premium Liquid Urine Controls DROPPER STYLE | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
12 | 20612479214938 | 163-89119 | Premium Liquid Urine Controls DROPPER STYLE | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
13 | 10885380151934 | CHUA260 | CHUA260 | UA Control Bottle Abnormal -240mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
14 | 10885380151927 | CHUA215 | CHUA215 | UA Control Tube Abnormal -90mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
15 | 10885380151910 | CHUA160 | CHUA160 | UA Control Bottle Normal -240mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
16 | 10885380151903 | CHUA115 | CHUA115 | UA Control Tube Normal -90mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
17 | 10885380151897 | CH1470-01 | CH1470-01 | UA Control Bottle Set -480mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
18 | 10885380151880 | CH1440-04 | CH1440-04 | UA Control Dropper Bottle Set -50mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
19 | 10885380151873 | CH1440-02 | CH1440-02 | UA Control Dropper Bottle Set-100mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
20 | 10885380151866 | CH1440-01 | CH1440-01 | UA Control Tube Set -90mL | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
21 | 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 |
22 | 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 |
23 | 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 |
24 | 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 |
25 | 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 |
26 | 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 |
27 | 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 |
28 | 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 |
29 | 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 |
30 | 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 |
31 | 10837461002710 | CalChek Kit | 800-7703 | iChem® VELOCITY™ CalChek Kit | iChem® VELOCITY™ | IRIS INTERNATIONAL, INC. |
32 | 10837461002680 | CA/CB/CC URINE CHEMSITRY CONTROLS | 800-7702 | IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS | IRISpec | IRIS INTERNATIONAL, INC. |
33 | 10837461002611 | CA/CB/CC URINE CHEMSITRY CONTROLS | 800-7211 | IRISPEC CA/CB/CC URINE CHEMISTRY CONTROLS | IRISpec | IRIS INTERNATIONAL, INC. |
34 | 10837461002178 | iQ® Control/Focus Set (NA/INTL) | 800-3104 | iQ® Control/Focus Set (NA/INTL) | iQ®200 | IRIS INTERNATIONAL, INC. |
35 | 10837461002147 | iQ® Calibrator | 800-3103 | iQ® Calibrator Pack | iQ®200 | IRIS INTERNATIONAL, INC. |
36 | 10837461002031 | iQ Precision Kit | 800-3014 | iQ Precision Kit | iQ®200 | IRIS INTERNATIONAL, INC. |
37 | 10837461001973 | CA/CB Twinset | 800-7211 | IRISpec CA/CB Twinset | IRISpec | IRIS INTERNATIONAL, INC. |
38 | 10612479197494 | 121-MAC | URINE TEST STRIP, MICRO ALBUMI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
39 | 05391516743204 | O6627 | O6627 | Oxalate Urine Control - N | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
40 | 05391516743198 | O6502 | O6502 | Oxalate Urine Control - E | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
41 | 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 | |
42 | 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 | |
43 | 05055273200546 | AU2353 | AU2353 | ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3) | RANDOX LABORATORIES LIMITED | |
44 | 05055273200539 | AU2352 | AU2352 | ASSAYED URINE CONTROL - LEVEL 2 (URN ASY CONTROL 2) | RANDOX LABORATORIES LIMITED | |
45 | 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. | |
46 | 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. | |
47 | 04250317546593 | 0373 | 0373 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
48 | 04250317546586 | 0372 | 0372 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
49 | 04250317546579 | 0381 | 0381 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
50 | 04250317546562 | 0382 | 0382 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |