| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
| 2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
| 3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
| 4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
| 5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
| 6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
| 7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
| 8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
| 9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
| 10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
| 11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
| 12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
| 13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
| 14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
| 15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
| 16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
| 17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
| 18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 20 | 07613336154403 | 03500373190 | 03500373190 | MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Ca Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | free PSA CalCheck | |
| 21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
| 22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
| 23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
| 24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
| 25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
| 26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
| 27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
| 28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
| 29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
| 30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
| 31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
| 32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
| 33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
| 34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
| 35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
| 36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
| 37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
| 38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
| 39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
| 40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
| 41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
| 42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
| 43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
| 44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
| 45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
| 46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
| 47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
| 48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
| 49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
| 50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 15099590225421 | 472467 | 472467 | Vigil TDM Control level 2 | Vigil | BECKMAN COULTER, INC. |
| 2 | 15099590225414 | 472472 | 472472 | Vigil TDM Control level 3 | Vigil | BECKMAN COULTER, INC. |
| 3 | 15099590225315 | 472461 | 472461 | Vigil TDM Control level 1 | Vigil | BECKMAN COULTER, INC. |
| 4 | 15099590223328 | 474976 | 474976 | SYNCHRON Systems DAT Multi-Drug Low Urine Control | Synchron | BECKMAN COULTER, INC. |
| 5 | 15099590223311 | 474979 | 474979 | SYNCHRON Systems DAT Multi-Drug High Urine Control | Synchron | BECKMAN COULTER, INC. |
| 6 | 15099590180225 | 469945 | 469945 | SYNCHRON Systems DAT Drug Free Urine Control | Synchron | BECKMAN COULTER, INC. |
| 7 | 10885380173172 | CH2465605 | CH2465605 | TDM/Beta-Hydroxybutyrate Bi-Level Controls | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 8 | 10885380173165 | CH2460605 | CH2460605 | TDM/Beta-Hydroxybutyrate Tri-Level Controls | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 9 | 10758750008957 | 1384007 | 1384007 | VITROS Chemistry Products Liquid Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 10 | 10758750005215 | 8962540 | 8962540 | VITROS Chemistry Products TDM Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 11 | 10758750004959 | 8466492 | 8466492 | VITROS Chemistry Products Liquid Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 12 | 10758750004508 | 8182172 | 8182172 | VITROS Chemistry Products TDM Performance Verifier III | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 13 | 10758750002658 | 6802331 | 6802331 | VITROS Chemistry Products DAT Performance Verifier V | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 14 | 10758750002641 | 6802330 | 6802330 | VITROS Chemistry Products DAT Performance Verifier IV | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 15 | 10758750002634 | 6802329 | 6802329 | VITROS Chemistry Products DAT Performance Verifier III | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 16 | 10758750002627 | 6802328 | 6802328 | VITROS Chemistry Products DAT Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 17 | 10758750002610 | 6802327 | 6802327 | VITROS Chemistry Products DAT Performance Verifier I | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 18 | 10758750000067 | 1792357 | 1792357 | VITROS Chemistry Products TDM Performance Verifier II | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 19 | 05391523441889 | 04S16-10 | Multichem WBT | TECHNO-PATH MANUFACTURING LIMITED | ||
| 20 | 05391523440233 | WB000A | Multichem WBT | TECHNO-PATH MANUFACTURING LIMITED | ||
| 21 | 05060500092030 | IR960-DAU | IR960-DAU | Multi-Analyte DAU Control Kit 4 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 22 | 05060500091675 | 0858 | 0858 | Drugs of Abuse Level 2 Control 1 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 23 | 05060500091668 | 0857 | 0857 | Drugs of Abuse Level 1 Control 1 X 15 mL | Synermed® | INFRARED LABORATORY SYSTEMS LLC |
| 24 | 05055273216264 | LV10355 | LV10355 | Therapeutic Drug Markers (TDM) Linearity Verifiers are an in vitro diagnostic pr Therapeutic Drug Markers (TDM) Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid and Vancomycin assays. | THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) | RANDOX LABORATORIES LIMITED |
| 25 | 05055273207927 | DA3124 | DA3124 | The Randox EDDP Control - Level 2 is intended for use in the Quality Control of The Randox EDDP Control - Level 2 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 2 contains the specific drug EDDP. | EDDP CONTROL 2 | RANDOX LABORATORIES LIMITED |
| 26 | 05055273207910 | DA3123 | DA3123 | The Randox EDDP Control - Level 1 is intended for use in the Quality Control of The Randox EDDP Control - Level 1 is intended for use in the Quality Control of the 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) assay. The EDDP Control - Level 1 contains the specific drug EDDP. | EDDP CONTROL 1 | RANDOX LABORATORIES LIMITED |
| 27 | 05055273207903 | DA3122 | DA3122 | The Randox Multidrug Control Level 2 is intended for use in the Quality Control The Randox Multidrug Control Level 2 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates assays. | DOA CONTROL 2 | RANDOX LABORATORIES LIMITED |
| 28 | 05055273207897 | DA3121 | DA3121 | The Randox Multidrug Control Level 1 is intended for use in the Quality Control The Randox Multidrug Control Level 1 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates assays. | DOA CONTROL 1 | RANDOX LABORATORIES LIMITED |
| 29 | 05055273203592 | HD1669 | This product is intended for in vitro diagnostic use in the quality control of d This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision. | DRUG CONTROL - LEVEL 3 (TDM CONTROL 3) | RANDOX LABORATORIES LIMITED | |
| 30 | 05055273203585 | HD1668 | This product is intended for in vitro diagnostic use in the quality control of d This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. The Drug Controls are for the control of accuracy and precision. | DRUG CONTROL - LEVEL 2 (TDM CONTROL 2) | RANDOX LABORATORIES LIMITED | |
| 31 | 05055273203578 | HD1667 | This product is intended for in vitro diagnostic use in the quality control of d This product is intended for in vitro diagnostic use in the quality control of drug residue analysis on clinical chemistry systems. TheDrug Controls are for the control of accuracy and precision. | DRUG CONTROL - LEVEL 1 (TDM CONTROL 1) | RANDOX LABORATORIES LIMITED | |
| 32 | 04015630997800 | 4590856190 | 4590856190 | Cfas DAT Qualitative Plus Clinical | ROCHE DIAGNOSTICS GMBH | |
| 33 | 04015630997794 | 4500873190 | 4500873190 | Control Set DAT Clinical | ROCHE DIAGNOSTICS GMBH | |
| 34 | 04015630996612 | 3312976190 | 3312976190 | Control Set DAT III | ROCHE DIAGNOSTICS GMBH | |
| 35 | 04015630996605 | 3312968190 | 3312968190 | Control Set DAT II | ROCHE DIAGNOSTICS GMBH | |
| 36 | 04015630996599 | 3312950190 | 3312950190 | Control Set DAT I | ROCHE DIAGNOSTICS GMBH | |
| 37 | 03610520863732 | 470X | 470X | Lyphochek Urine Toxicology Control MiniPak (A human urine drugs of abuse control) | Lyphochek | BIO-RAD LABORATORIES, INC. |
| 38 | 00884883011694 | PTD-S1 | MAS PAR TDM Liquid Assayed Therapeutic Drug Control | MICROGENICS CORPORATION | ||
| 39 | 00884883004856 | 1815440 | CEDIA Speciality Control Set | MICROGENICS CORPORATION | ||
| 40 | 00884883004801 | 100069 | CEDIA MultiDrug Optional Controls | MICROGENICS CORPORATION | ||
| 41 | 00884883004733 | DOAT-MP | MAS DOA Total Liquid Assayed Drugs of Abuse Control | MICROGENICS CORPORATION | ||
| 42 | 00884883004726 | DOAT-6 | MAS DOA Total Liquid Assayed Drugs of Abuse Control | MICROGENICS CORPORATION | ||
| 43 | 00884883004719 | DOAT-5 | MAS DOA Total Liquid Assayed Drugs of Abuse Control | MICROGENICS CORPORATION | ||
| 44 | 00884883004702 | DOAT-4 | MAS DOA Total Liquid Assayed Drugs of Abuse Control | MICROGENICS CORPORATION | ||
| 45 | 00884883004696 | DOAT-3 | MAS DOA Total Liquid Assayed Drugs of Abuse Control | MICROGENICS CORPORATION | ||
| 46 | 00884883004689 | DOAT-2 | MAS DOA Total Liquid Assayed Drugs of Abuse Control | MICROGENICS CORPORATION | ||
| 47 | 00884883004672 | DOAT-1 | MAS DOA Total Liquid Assayed Drugs of Abuse Control | MICROGENICS CORPORATION | ||
| 48 | 00884883003880 | 10011608 | MAS Tox Control Liquid Assayed Toxicology Control | MICROGENICS CORPORATION | ||
| 49 | 00884883002432 | PTD3-3003 | MAS PAR TDM Liquid Assayed Therapeutic Drug Control | MICROGENICS CORPORATION | ||
| 50 | 00884883002425 | PTD2-2002 | MAS PAR TDM Liquid Assayed Therapeutic Drug Control | MICROGENICS CORPORATION |