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 | 05055273207880 | DA2704 | DA2704 | The Randox Multidrug Calibrator Set is intended for use in the calibration of Me The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays. | DOA CAL | RANDOX LABORATORIES LIMITED |
2 | 05055273207866 | DA2702 | DA2702 | The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-e The Randox EDDP Calibrator Set is intended for use in the calibration of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. | EDDP CAL | RANDOX LABORATORIES LIMITED |
3 | 05055273206470 | TD3417 | TD3417 | This product is intended for use in the calibration of therapeutic drug assays. | TDM CAL | RANDOX LABORATORIES LIMITED |
4 | 05055273202458 | EV3550 | EV3550 | Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser. | DOA CAL | RANDOX LABORATORIES LIMITED |
5 | 04015630996971 | 3375781190 | 3375781190 | Preciset TDM II | ROCHE DIAGNOSTICS GMBH | |
6 | 04015630996964 | 3375790190 | 3375790190 | Preciset TDM I | ROCHE DIAGNOSTICS GMBH | |
7 | 04015630996582 | 3304698190 | 3304698190 | Cfas DAT Qualitiative Plus | ROCHE DIAGNOSTICS GMBH | |
8 | 04015630996575 | 3304680190 | 3304680190 | Preciset DAT Plus II | ROCHE DIAGNOSTICS GMBH | |
9 | 04015630996568 | 3304671190 | 3304671190 | Preciset DAT Plus I | ROCHE DIAGNOSTICS GMBH | |
10 | 04015630995172 | 11815253216 | 11815253216 | CEDIA Core TDM MultiCal | ROCHE DIAGNOSTICS GMBH | |
11 | 04015630995158 | 11815245216 | 11815245216 | CEDIA Antibiotic TDM Multi-Cal | ROCHE DIAGNOSTICS GMBH | |
12 | 04015630994533 | 20766356122 | 20766356122 | LSD CalibrationControl Pack | ROCHE DIAGNOSTICS GMBH | |
13 | 04015630935048 | 7007515190 | 7007515190 | ACET2 calibrator | ROCHE DIAGNOSTICS GMBH | |
14 | 00884883011571 | 1594 | DRI Multi-Drug Urine Calibrator 3 | MICROGENICS CORPORATION | ||
15 | 00884883011557 | 1815326 | CEDIA Multi-Drug Calibrator Primary Cutoffs | MICROGENICS CORPORATION | ||
16 | 00884883011502 | 1597 | DRI Multi-Drug Urine Calibrator 4 | MICROGENICS CORPORATION | ||
17 | 00884883011489 | 1557416 | CEDIA Negative Calibrator | MICROGENICS CORPORATION | ||
18 | 00884883011458 | 1588 | DRI Multi-Drug Urine Calibrator 1 | MICROGENICS CORPORATION | ||
19 | 00884883011045 | 10014954 | CEDIA Multi-Drug OFT Negative Calibrator | MICROGENICS CORPORATION | ||
20 | 00884883011038 | 10014955 | CEDIA Multi-Drug OFT Cutoff Calibrator | MICROGENICS CORPORATION | ||
21 | 00884883010987 | 10014957 | CEDIA Multi-Drug OFT Control Set | MICROGENICS CORPORATION | ||
22 | 00884883007116 | 08777934 190 | CEDIA Antibiotic TDM Multi-Cal | MICROGENICS CORPORATION | ||
23 | 00884883005969 | 1388 | DRI Negative Urine Calibrator | MICROGENICS CORPORATION | ||
24 | 00884883005914 | 100033 | CEDIA Multi-Drug Optional Cutoff Calibrator | MICROGENICS CORPORATION | ||
25 | 00884883005235 | 1598 | DRI Multi-Drug Urine Calibrator 4 | MICROGENICS CORPORATION | ||
26 | 00884883005228 | 1595 | DRI Multi-Drug Urine Calibrator 3 | MICROGENICS CORPORATION | ||
27 | 00884883005211 | 1592 | DRI Multi-Drug Urine Calibrator 2 | MICROGENICS CORPORATION | ||
28 | 00884883005143 | 1589 | DRI Multi-Drug Urine Calibrator 1 | MICROGENICS CORPORATION | ||
29 | 00884883005044 | 0036 | DRI Drugs of Abuse High Calibrator | MICROGENICS CORPORATION | ||
30 | 00884883004825 | 1815334 | CEDIA Multi-Drug Calibrator Primary Cutoffs | MICROGENICS CORPORATION | ||
31 | 00884883002647 | 1591 | DRI Multi-Drug Urine Calibrator 2 | MICROGENICS CORPORATION | ||
32 | 00884883002531 | 0034 | DRI Drugs of Abuse Low Calibrator | MICROGENICS CORPORATION | ||
33 | 00884883002067 | 1732226 | CEDIA Multi-Drug High Calibrator | MICROGENICS CORPORATION | ||
34 | 00884883002050 | 1732218 | CEDIA Multi-Drug Intermediate Calibrator | MICROGENICS CORPORATION | ||
35 | 00884883002043 | 1730517 | CEDIA Multi-Drug Calibrator Secondary Cutoffs | MICROGENICS CORPORATION | ||
36 | 00884883002036 | 1730428 | CEDIA Multi-Drug Calibrator Secondary Cutoffs | MICROGENICS CORPORATION | ||
37 | 00884883002029 | 1730401 | CEDIA Multi-Drug Calibrator Clinical Cutoffs | MICROGENICS CORPORATION | ||
38 | 00884883002012 | 1730398 | CEDIA Multi-Drug High Calibrator | MICROGENICS CORPORATION | ||
39 | 00884883002005 | 1730380 | CEDIA Multi-Drug Intermediate Calibrator | MICROGENICS CORPORATION | ||
40 | 00884883001961 | 1661388 | CEDIA Negative Calibrator | MICROGENICS CORPORATION | ||
41 | 00884883001329 | 100017 | CEDIA AntibioticTDM Multi-Calibrator | MICROGENICS CORPORATION | ||
42 | 00884883001190 | 1664 | DRI Negative Urine Calibrator | MICROGENICS CORPORATION | ||
43 | 00884883001138 | 0976 | DRI Serum Tox Calibrator 4 | MICROGENICS CORPORATION | ||
44 | 00884883001121 | 0967 | DRI Serum Tox Calibrator 3 | MICROGENICS CORPORATION | ||
45 | 00884883001114 | 0965 | DRI Serum Tox Calibrator 2 | MICROGENICS CORPORATION | ||
46 | 00884883001107 | 0963 | DRI Serum Tox Calibrator 1 | MICROGENICS CORPORATION | ||
47 | 00884883001091 | 0962 | DRI Serum Tox Negative Calibrator | MICROGENICS CORPORATION | ||
48 | 00859110005050 | 301vt | 301vt | Validate TDM1vt is intended for the quantitative determination of Calibration Ve Validate TDM1vt is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
49 | 00859110005043 | 301ri | 301ri | Validate TDM1ri is intended for the quantitative determination of Calibration Ve Validate TDM1ri is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
50 | 00859110005036 | 301db | 301db | Validate TDM1db is intended for the quantitative determination of Calibration Ve Validate TDM1db is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |