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 | 00868665000076 | 3S-01-16003A | 3S-01-16003A | Rosie SmartMeter Blood Glucose GDH-FAD Test Strips | Rosie SmartMeter Test Strips 50ct(vial) | HMD BIOMEDICAL INC. |
2 | 00868665000069 | 3C-01-160033 | 3C-01-160033 | Rosie SmartMeter glucose control solution | Rosie SmartMeter Glucose Control Solutions | HMD BIOMEDICAL INC. |
3 | 00860394001294 | CURO Glucose Strips | CURO Glucose Strips for G6 and G6s | CURO Glucose Strips | KPI HEALTHCARE, INC. | |
4 | 00860394001263 | CURO G6 Glucose Meter | CURO G6 Glucose Meter | CURO G6 Glucose Meter | KPI HEALTHCARE, INC. | |
5 | 00860394001256 | CURO L5 Total Cholesterol Strips | Total Cholesterol Strips | CURO L5 Total Cholesterol Strips | KPI HEALTHCARE, INC. | |
6 | 00860394001225 | CURO L5 CURO L5 | CURO L5 Cholesterol and Glucose measuring system | CURO L5 | KPI HEALTHCARE, INC. | |
7 | 00860006589721 | 2015-0232 | ACCURUN Anti-SRAS-COV-2 IgM Controls Kit | ACCURUN Anti SARS-COV-2 IgM Controls Kit | LGC CLINICAL DIAGNOSTICS, INC. | |
8 | 00859519002056 | CS | TC0003 | Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips. | BioTel Care® Double Control Solution | TELCARE, LLC |
9 | 00859110005951 | 607ro | 607ro | Validate Whole Blood Glucose (WBG) is intended for the quantitative determinatio Validate Whole Blood Glucose (WBG) is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
10 | 00859110005944 | 605to | 605to | Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
11 | 00859110005937 | 605 | 605 | Validate HbA1c is intended for the quantitative determination of Calibration Ver Validate HbA1c is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
12 | 00859110005852 | 506vt | 506vt | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
13 | 00859110005845 | 506ab | 506ab | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
14 | 00859110005838 | 506 | 506 | Validate Vit D is intended for the quantitative determination of Calibration Ver Validate Vit D is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
15 | 00859110005715 | 406re | 406re | Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
16 | 00859110005708 | 406bc | 406bc | Validate PSA is intended for the quantitative determination of Calibration Verif Validate PSA is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
17 | 00859110005678 | 403ro | 403ro | Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
18 | 00859110005661 | 403ab | 403ab | Validate PCT is intended for the quantitative determination of Calibration Verif Validate PCT is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
19 | 00859110005562 | 307 | 307 | Validate Ferritin is intended for the quantitative determination of Calibration Validate Ferritin is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments. | Validate | LGC CLINICAL DIAGNOSTICS, INC. |
20 | 00857969006426 | C2-86 | C2-86 | Hemoglobin A1c Controls | Alfa Wassermann | ALFA WASSERMANN, INC. |
21 | 00857596008022 | AC-11 AC302 | 3K-01-16003R | GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type. | GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) | HMD BIOMEDICAL INC. |
22 | 00856626006106 | 995-06101 | 995-06101 | In-Vitro Diagnostic Use | Autokit Micro Albumin Calibrator Set | FUJIFILM WAKO PURE CHEMICAL CORPORATION |
23 | 00856522006095 | 074446 | 074402 | Creatinine Control Kit | Creatinine Control Kit | LIFEHEALTH |
24 | 00856176008032 | 00856176008032 | 00856176008032 | Level 2 Control Solution (150 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
25 | 00856176008025 | 00856176008025 | 00856176008025 | Level 1 Control Solution (75 mg/dL) | POGO Automatic Control Solution | INTUITY MEDICAL, INC. |
26 | 00855574005391 | HCG-POCU | Qualitative HCG Control, Urine | Poly stat | POLYMEDCO, INC. | |
27 | 00855574005377 | HCG-POC | Qualitative HCG Control | Poly stat | POLYMEDCO, INC. | |
28 | 00854427007148 | KIT - Glucose Monitoring System | Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lan Glucose Meter Kit: 1 meter, 1 lancing device, 1 carrying bag, 10 pcs sterile lancets, 1 logbook, 1 user manual | HEPRO.US MM1000 Blood Glucose Monitoring System Kit | HEPRO.US INC. | |
29 | 00854067005238 | EHS-SDMK-V | Smart Diabetes Voice Glucose Monitor | Smart Diabetes | VALUE PROVIDERS LLC | |
30 | 00854067005191 | EHS-SDMK-BT | Smart Diabetes Bluetooth Glucose Monitor | Eocene | VALUE PROVIDERS LLC | |
31 | 00853553005257 | Livongo G1.5 | KIT00441 | Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of L Livongo Welcome Kit G1.5 with BG200, 3 vials of Livongo Test strips, 4 bags of Livongo Sterile Lancets, 1 box of Livongo Control Solution high/low, 1 Livongo Lancing device, 1 Livongo Carrying case, 1 charger, 1 charger cable, 1 Instructions for Use (English), 1 Instructions for Use (Spanish), 1 User Guide (English), 1 User Guide (Spanish) | Livongo Welcome Kit | LIVONGO HEALTH, INC |
32 | 00853553005202 | Livongo | OFG00426 | Livongo Control Solution with 1 bottle high / 1 bottle low | Livongo Control Solution | LIVONGO HEALTH, INC |
33 | 00853553005158 | In Touch | OFG00155 | In Touch Control solution with 1 bottle high, 1 bottle low | In Touch Glucose Control Solution | LIVONGO HEALTH, INC |
34 | 00853553005103 | In Touch | KIT00147 | 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch hi 6 boxes of In Touch Test Strips, 1 box of In Touch Lancets, 1 box of In Touch high/low Control Solution | In Touch Refill Kit | LIVONGO HEALTH, INC |
35 | 00853553005028 | In Touch | OFG00140 | Box of High/Low Control Solution | In Touch Glucose Control Solutions | LIVONGO HEALTH, INC |
36 | 00853483008199 | VGC01 | VGC01-372 | VivaGuard Ino Control Solution (1 & 3) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
37 | 00853483008175 | VGC01 | VGC01-373 | VivaGuard Ino Control Solution 2 (1 bottle/kit) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
38 | 00853483008076 | VGC01 | VGC01-371 | VivaGuard Ino Control Solution (L, M, H, 1 bottle/each) | VivaGuard Ino | ABLE DIAGNOSTICS INC |
39 | 00852668007187 | BLE-CS3 | Control Solution Box 3 Pack | BLE Smart® Control Solution | ENTRA HEALTH SYSTEMS LLC | |
40 | 00850578007396 | CT Glucosemeter kits | Case/Carton of 40 boxes of ONE GLUCOSEMETER KIT HEPRO.US MM1000 Copy | HEPRO.US MM1000 BRAND CT40 GLUCOSEMETER KIT - | HEPRO.US INC. | |
41 | 00850229007195 | 405 | E002-405 | Analyzer Quality Control | DriDye 405 | AWARENESS TECHNOLOGY, INCORPORATED |
42 | 00850229007188 | 405/ 450 | Analyzer Quality Control | DriDye 405/ 450 | AWARENESS TECHNOLOGY, INCORPORATED | |
43 | 00850229007171 | 450 | E002-450 | Analyzer Quality Control | DriDye 450 | AWARENESS TECHNOLOGY, INCORPORATED |
44 | 00850229007164 | 492 | E002-492 | Analyzer Quality Control | DriDye 492 | AWARENESS TECHNOLOGY, INCORPORATED |
45 | 00850212007089 | 2130166 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
46 | 00850212007034 | 2130152 | Vitamin D Control | FUJIREBIO DIAGNOSTICS, INC. | ||
47 | 00850081003212 | MGH-CS3 | Control Solution 3 Pak | MyGlucoHealth® Control Solution 3-Pack | ENTRA HEALTH SYSTEMS LLC | |
48 | 00850065006215 | 1054-05 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
49 | 00850065006048 | 1054-01 | Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitor Dario® Glucose Control Solution is for use with the Dario® Blood Glucose Monitoring System manufactured by Labstyle Innovation Ltd. to check that the meter and test strips are working together properly for self-testing. | Dario Glucose Control Solution | LABSTYLE INNOVATION LTD | |
50 | 00850017460058 | S5800382 | S5800382 | Level 1 & 2 | BIOCOACH Glucose Control Solution L1/L2 | AMVENTUREX, INC. |