| 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 | 00884883010987 | 10014957 | DKB | Calibrators, Drug Mixture | 2 | CEDIA Multi-Drug OFT Control Set | ||
| 9 | 00884883007529 | 10027482 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS anti-HBs Positive Control | ||
| 10 | 00884883007512 | 10027481 | OHQ | Multi-Analyte Controls Unassayed | 1 | MAS HIV p24 Positive Control | ||
| 11 | 00884883006966 | 10023647 | QDR | Plazomicin Test System, Immunoassay | 2 | QMS Plazomicin Immunoassay | ||
| 12 | 00884883006959 | 969035 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix Syphilis | ||
| 13 | 00884883006546 | 964003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 High Control | ||
| 14 | 00884883006478 | 964001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HIV-1 Low Control | ||
| 15 | 00884883006454 | 963001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix HCV Low Control | ||
| 16 | 00884883006386 | 960041 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix GBS Positive Control | ||
| 17 | 00884883006027 | 963603 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Acrometrix BB NAT HBV Positive Control | ||
| 18 | 00884883005969 | 1388 | DKB | Calibrators, Drug Mixture | 2 | DRI Negative Urine Calibrator | ||
| 19 | 00884883005891 | 963602 | MYZ | Kit,Test(Donors),For Bloodborne Pathogen | 2 | Acrometrix BB NAT HIV-1 POS. CTRL | ||
| 20 | 00884883005594 | 0920 | JXM | Enzyme Immunoassay, Benzodiazipine | 2 | DRI Benzodiazepine Serum Tox Assay | ||
| 21 | 00884883005587 | 0911 | DIS | Enzyme Immunoassay, Barbiturate | 2 | DRI Barbiturate Serum Tox Assay | ||
| 22 | 00884883005501 | 100282 | JQY | Ph Meter | 1 | DRI pH-Detect pH 3.6 Control Kit | ||
| 23 | 00884883005174 | 100255 | LAS | Drug Specific Control Materials | 1 | DRI Oxycodone 300 Controls | ||
| 24 | 00884883005082 | 100117 | DLJ | Calibrators, Drug Specific | 2 | DRI Methadone Metabolite 150 ng/mL Calibrator | ||
| 25 | 00884883004771 | 1732153 | DLJ | Calibrators, Drug Specific | 2 | CEDIA LSD Cutoff Calibrator | ||
| 26 | 00884883004399 | 10014182 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
| 27 | 00884883004382 | 10014181 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
| 28 | 00884883004375 | 10014180 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
| 29 | 00884883004368 | 10014179 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
| 30 | 00884883004337 | 1815296 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDUA DAU Opiate 2K | ||
| 31 | 00884883004160 | 024227 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
| 32 | 00884883004153 | 024224 | JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | MAS Urinalysis Liquid Urinalysis Control 3 | ||
| 33 | 00884883004108 | 1661248 | DJG | Enzyme Immunoassay, Opiates | 2 | CEDIA DAU Opiate | ||
| 34 | 00884883003798 | CHU-SP | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS® ChemTRAK H Unassayed Control Sample Pack | ||
| 35 | 00884883003637 | LG-S1 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
| 36 | 00884883003613 | CAI-XLS | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
| 37 | 00884883003606 | CAI-XL4 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
| 38 | 00884883003477 | 100248 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
| 39 | 00884883003415 | 0514 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
| 40 | 00884883003347 | 10013878 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
| 41 | 00884883003330 | 10013877 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
| 42 | 00884883003323 | 10013876 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
| 43 | 00884883002968 | 100249 | DJG | Enzyme Immunoassay, Opiates | 2 | DRI Oxycodone Assay | ||
| 44 | 00884883002937 | 0515 | KXS | Radioimmunoassay, Methaqualone | 2 | DRI Methaqualone Assay | ||
| 45 | 00884883002920 | 100116 | DJR | Enzyme Immunoassay, Methadone | 2 | DRI Methadone Metabolite Assay | ||
| 46 | 00884883002401 | LIG-303 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
| 47 | 00884883002395 | LIG-202 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
| 48 | 00884883002388 | LIG-101 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS Liquimmune Liquid Assayed Immunoassay Control | ||
| 49 | 00884883002371 | CAI-XLL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | MAS CardioImmune XL Liquid Assayed Cardiac Marker Control | ||
| 50 | 00884883002364 | CAI-XL3 | 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 | 00884883011274 | 0374090 | QMS Lamotrigine Immunoassay | MICROGENICS CORPORATION | ||
| 2 | 00884883011250 | 0374181 | QMS Topiramate Immunoassay Control set | MICROGENICS CORPORATION | ||
| 3 | 00884883011229 | 0373373 | QMS Zonisamide Immunoassay Control Set | MICROGENICS CORPORATION | ||
| 4 | 00884883011151 | 10014953 | CEDIA Methamphetamine OFT Controls | MICROGENICS CORPORATION | ||
| 5 | 00884883006980 | 10023697 | QMS Plazomicin Immunoassay Control | MICROGENICS CORPORATION | ||
| 6 | 00884883006843 | 10024435 | DRI MDA Control | MICROGENICS CORPORATION | ||
| 7 | 00884883005709 | 10014925 | CEDIA THC OFT Controls Kit | MICROGENICS CORPORATION | ||
| 8 | 00884883005174 | 100255 | DRI Oxycodone 300 Controls | MICROGENICS CORPORATION | ||
| 9 | 00884883005167 | 100254 | DRI Oxycodone 100 Controls | MICROGENICS CORPORATION | ||
| 10 | 00884883004870 | 1661060 | CEDIA DAU THC 100 Control Set | MICROGENICS CORPORATION | ||
| 11 | 00884883004863 | 1661086 | CEDIA DAU THC 25 Control Set | MICROGENICS CORPORATION | ||
| 12 | 00884883004832 | 10020804 | CEDIA Buprenorphine II Controls | MICROGENICS CORPORATION | ||
| 13 | 00884883004597 | 0373878 | QMS Everolimus Immunoassay Control Set | MICROGENICS CORPORATION | ||
| 14 | 00884883001954 | 1661078 | CEDIA DAU THC 50 Control Set | MICROGENICS CORPORATION | ||
| 15 | 00884883001848 | 100280 | MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control | MICROGENICS CORPORATION | ||
| 16 | 00884883001831 | 100279 | MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control | MICROGENICS CORPORATION | ||
| 17 | 00884883001824 | 100278 | MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Control | MICROGENICS CORPORATION | ||
| 18 | 00884883001756 | 100246 | CEDIA Buprenorphine Controls | MICROGENICS CORPORATION | ||
| 19 | 00884883000360 | 10018149 | DRI Hydrocodone Controls | MICROGENICS CORPORATION | ||
| 20 | 00869335000259 | A68825 | A68825 | 5mL/bottle.Concentration: 13 ng/mL of Norbuprenorphine. | Norbuprenorphine DAU Control, Level 2 Control | LIN-ZHI INTERNATIONAL, INC. |
| 21 | 00869335000235 | A68824 | A68824 | 5mL/bottle.Concentration: 7 ng/mL of Norbuprenorphine. | Norbuprenorphine DAU Control, Level 1 Control | LIN-ZHI INTERNATIONAL, INC. |
| 22 | 00858724003926 | 5051-0003-01 | 5051-0003-01 | ARK™ EDDP Control is intended for use in quality control of the ARK™ EDDP Assay. | ARK™ EDDP Control (225/375) | ARK DIAGNOSTICS INC |
| 23 | 00858724003919 | 5051-0003-00 | 5051-0003-00 | ARK™ EDDP Control is intended for use in quality control of the ARK™ EDDP Assay. | ARK™ EDDP Control (75/125) | ARK DIAGNOSTICS INC |
| 24 | 00858724003834 | 5040-0003-00 | 5040-0003-00 | ARK™ Tramadol Control is intended for use in quality control of the ARK™ Tramadol Assay. | ARK™ Tramadol Control | ARK DIAGNOSTICS INC |
| 25 | 00858724003766 | 5036-0006-01 | 5036-0006-01 | ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay. | ARK™ Ethyl Glucuronide Control (750/1250) | ARK DIAGNOSTICS INC |
| 26 | 00858724003759 | 5036-0006-00 | 5036-0006-00 | ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay. | ARK™ Ethyl Glucuronide Control (375/625) | ARK DIAGNOSTICS INC |
| 27 | 00858724003698 | 5052-0003-00 | 5052-0003-00 | ARK™ Fentanyl Control is intended for use in quality control of the ARK™ Fentanyl Assay. | ARK™ Fentanyl Control (WPT) | ARK DIAGNOSTICS INC |
| 28 | 00858724003568 | 5042-0003-00 | 5042-0003-00 | ARK™ Methylphenidate Metabolite Control is intended for use in quality control o ARK™ Methylphenidate Metabolite Control is intended for use in quality control of the ARK™ Methylphenidate Metabolite Assay. | ARK™ Methylphenidate Metabolite Control | ARK DIAGNOSTICS INC |
| 29 | 00858724003506 | 5036-0003-01 | 5036-0003-01 | ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay. | ARK™ Ethyl Glucuronide Control (750/1250) | ARK DIAGNOSTICS INC |
| 30 | 00858724003490 | 5036-0003-00 | 5036-0003-00 | ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK ARK™ Ethyl Glucuronide Control is intended for use in quality control of the ARK™ Ethyl Glucuronide Assay. | ARK™ Ethyl Glucuronide Control (375/625) | ARK DIAGNOSTICS INC |
| 31 | 00858724003421 | 5031-0003-00 | 5031-0003-00 | ARK™ Fentanyl Control is intended for use in quality control of the ARK™ Fentanyl Assay. | ARK™ Fentanyl Control | ARK DIAGNOSTICS INC |
| 32 | 00858724003391 | 5026-0003-03 | 5026-0003-03 | The ARK™ Methotrexate Control consists of a three-level set used for quality con The ARK™ Methotrexate Control consists of a three-level set used for quality control of the assay (tri-level calibration range set). The controls consist of a synthetic protein matrix and the levels are 0.07 umol/L, 0.40 umol/L and 0.80umol/L. | ARK™ Methotrexate Control | ARK DIAGNOSTICS INC |
| 33 | 00858724003353 | 5033-0003-00 | 5033-0003-00 | The ARK™ Lacosamide Control is intended for use in quality control of the ARK™ The ARK™ Lacosamide Control is intended for use in quality control of the ARK™ Lacosamide Assay. | ARK™ Lacosamide Control | ARK DIAGNOSTICS INC |
| 34 | 00858724003322 | 5032-0003-00 | 5032-0003-00 | The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material The ARK™ Oxcarbazepine Metabolite Control is an assayed quality control material intended for use in quality control of the ARK™ Oxcarbazepine Metabolite Assay. | ARK™ Oxcarbazepine Metabolite Control | ARK DIAGNOSTICS INC |
| 35 | 00858724003285 | 5035-0003-00 | 5035-0003-00 | ARK™Pregabalin Urine Control is intended for use in quality control of the ARK™P ARK™Pregabalin Urine Control is intended for use in quality control of the ARK™Pregabalin Urine Assay. | ARK™ Pregabalin Urine Control | ARK DIAGNOSTICS INC |
| 36 | 00858724003193 | 5026-0003-02 | 5026-0003-02 | The ARK™ Methotrexate Control consists of a three-level set used for quality con The ARK™ Methotrexate Control consists of a three-level set used for quality control of the assay (tri-level high range set). The controls consist of a synthetic protein matrix and the levels are 5 umol/L, 50 umol/L and 500 umol/L.) | ARK™ Methotrexate Control | ARK DIAGNOSTICS INC |
| 37 | 00858724003186 | 5026-0003-01 | 5026-0003-01 | The ARK™ Methotrexate Control consists of a three-level set used for quality con The ARK™ Methotrexate Control consists of a three-level set used for quality control of the assay (tri-level calibration range set). The controls consist of a synthetic protein matrix and the levels are 0.07 umol/L, 0.40 umol/L and 0.80umol/L. | ARK™ Methotrexate Control | ARK DIAGNOSTICS INC |
| 38 | 00858724003179 | 5026-0003-00 | 5026-0003-00 | The ARK™ Methotrexate Control consists of a six-level set used for quality contr The ARK™ Methotrexate Control consists of a six-level set used for quality control of the assay (tri-level calibration range set and tri-level high range set). The controls consist of a synthetic protein matrix and the levels are 0.07 umol/L, 0.40 umol/L, 0.80umol/L, 5 umol/L, 50 umol/L and 500 umol/L. | ARK™ Methotrexate Control | ARK DIAGNOSTICS INC |
| 39 | 00858724003162 | 5025-0003-00 | 5025-0003-00 | The ARK™ Gabapentin Control is intended for use in quality control of the ARK The ARK™ Gabapentin Control is intended for use in quality control of the ARK™Gabapentin Assay. | ARK™ Gabapentin Control | ARK DIAGNOSTICS INC |
| 40 | 00858724003155 | 5024-0003-00 | 5024-0003-00 | The ARK™ Levetiracetam Control is intended for use in quality control of the The ARK™ Levetiracetam Control is intended for use in quality control of the ARK™Levetiracetam Assay. | ARK™ Levetiracetam Control | ARK DIAGNOSTICS INC |
| 41 | 00858724003148 | 5023-0003-00 | 5023-0003-00 | The ARK™ Lamotrigine Control is intended for use in quality control of the AR The ARK™ Lamotrigine Control is intended for use in quality control of the ARK™Lamotrigine Assay. | ARK™ Lamotrigine Control | ARK DIAGNOSTICS INC |
| 42 | 00858724003131 | 5022-0003-00 | 5022-0003-00 | The ARK™ Zonisamide Control is intended for use in quality control of the ARK The ARK™ Zonisamide Control is intended for use in quality control of the ARK™Zonisamide Assay. | ARK™ Zonisamide Control | ARK DIAGNOSTICS INC |
| 43 | 00858724003124 | 5015-0003-00 | 5015-0003-00 | The ARK™ Topiramate Control consists of a three-level set used for quality cont The ARK™ Topiramate Control consists of a three-level set used for quality control of the ARK™ Topiramate Assay. | ARK™ Topiramate Control | ARK DIAGNOSTICS INC |
| 44 | 00856743007109 | 240-4 | 240-4 | MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid. | MPA Control | MORE DIAGNOSTICS INC |
| 45 | 00856743007093 | 240-3 | 240-3 | MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid. | MPA Control | MORE DIAGNOSTICS INC |
| 46 | 00856743007086 | 240-2 | 240-2 | MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid. | MPA Control | MORE DIAGNOSTICS INC |
| 47 | 00856743007079 | 240-1 | 240-1 | MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid. | MPA Control | MORE DIAGNOSTICS INC |
| 48 | 00856743007062 | 240 | 240 | MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid. | MPA Control | MORE DIAGNOSTICS INC |
| 49 | 00856743007055 | 202 | 202 | MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood. | Cyclosporine C2 Control | MORE DIAGNOSTICS INC |
| 50 | 00850624008483 | C68829 | C68829 | HYD 300 Level 2 Control 375 ng/mL (1 x 5 mL) | LZI Hydrocodone 300 Level 2 Control | LIN-ZHI INTERNATIONAL, INC. |