No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08809301161029 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
2 | 08809301160411 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate Smart Blood Glucose Monitoring System | ||
3 | 08809301162194 | PC001-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Low | ||
4 | 08809301162200 | PC002-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution Normal | ||
5 | 08809301161036 | PS-004 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | Gmate® Blood Glucose Test Strips | |||
6 | 08809301162026 | PC-003 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 3 | ||
7 | 08809301161760 | PS-004 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | Pip Blood Glucose Test Strips | |||
8 | 08809301168059 | GT-C01 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 1 | ||
9 | 08809301160152 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
10 | 08809301160114 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
11 | 08809301160015 | PG-200 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® mini Blood Glucose Monitoring System | ||
12 | 08809301160862 | PG-310 | NBW,CGA | System, Test, Blood Glucose, Over The Counter,Glucose Oxidase, Glucose | 2 | Pip Blood Glucose Monitoring System | ||
13 | 08809301160213 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
14 | 08809301160138 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
15 | 08809301160084 | PG-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® VOICE Blood Glucose Monitoring System | ||
16 | 08809301168066 | GT-C02 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | GlucoTrack Solution Level 2 | ||
17 | 08809301168134 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
18 | 08809301168127 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
19 | 08809301168110 | GT-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack SMART Blood Glucose Monitoring System | ||
20 | 08809301162057 | PC-001 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 1 | ||
21 | 08809301162019 | PC-002 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Gmate® Control Solution Level 2 | ||
22 | 08809301168042 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
23 | 08809301168011 | GT-S01 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | GlucoTrack Blood Glucose Test Strips | |||
24 | 08809301160206 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
25 | 08809301160145 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
26 | 08809301160077 | PG-310 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® Origin Blood Glucose Monitoring System | ||
27 | 08809301168103 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
28 | 08809301168097 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack VOICE Blood Glucose Monitoring System | ||
29 | 08809301168080 | GT-301 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | GlucoTrack Voice Blood Glucose Monitoring System | ||
30 | 08809301166031 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
31 | 08809301166017 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
32 | 08809301166000 | PG-101 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® SMART Blood Glucose Monitoring System | ||
33 | 08809301162217 | PC003-US | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pip Control Solution High | ||
34 | 08809301160169 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
35 | 08809301160121 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System | ||
36 | 08809301160022 | PG-201 | CGA,NBW | Glucose Oxidase, Glucose,System, Test, Blood Glucose, Over The Counter | 2 | Gmate® STEP Blood Glucose Monitoring System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00814247020468 | ROM-QCS | ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test | ROM Plus® Strip Quality Control | CLINICAL INNOVATIONS, LLC | |
2 | 00814247020451 | ROM-QC | ROM Plus®, Quality Control for Fetal Membranes Rupture Test | ROM Plus® Quality Control Kit | CLINICAL INNOVATIONS, LLC | |
3 | 00812277030068 | 2762-32702 | 2762-32702 | Curaplex Control Solution 2/BT | Curaplex | BOUND TREE MEDICAL, LLC |
4 | 00811727015594 | L7597-CTL | L7597-CTL | Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitorin Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For in vitro diagnostic use. | Pointe Lipoprotein (a) Control Set | POINTE SCIENTIFIC, INC. |
5 | 00810042683181 | 702012 | 702012 | HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
6 | 00810042683174 | 18003155 | hCG Low Positive/Negative Urine 2x5mL Kitbox | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
7 | 00810042683129 | 2110005 | 18000347 | CenMed hCG URINE Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
8 | 00810042683112 | 2110007 | 18000346 | CenMed hCG URINE Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
9 | 00810042682962 | 2122015 | 18000698 | CenMed hCG Serum Control POSITIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
10 | 00810042682948 | 2122017 | 18000697 | CenMed hCG Serum Control NEGATIVE, 5mL | CENMED | BIOCHEMICAL DIAGNOSTICS INC |
11 | 00810042682900 | Custom QC31 | PREGNANCY SKREEN Custom hCG Serum 4mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
12 | 00810042682894 | Custom QC30 | PREGNANCY SKREEN Custom hCG Serum 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
13 | 00810042681415 | Custom QC25 | PREGNANCY SKREEN Custom hCG Liquid Urine 50mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
14 | 00810042681408 | Custom QC24 | PREGNANCY SKREEN Custom hCG Liquid Urine 20mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
15 | 00810042681392 | Custom QC23 | PREGNANCY SKREEN Custom hCG Liquid Urine 5mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
16 | 00810042681385 | Custom QC22 | PREGNANCY SKREEN Custom hCG Liquid Urine 2mL | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
17 | 00810042681347 | Custom QC18 | PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC | |
18 | 00810042681156 | 18030367 | 18030367 | HCG Urine 2x4mL dropper Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
19 | 00810042681095 | 18000656 | 18000656 | CONSULT HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
20 | 00810042681088 | 18000443 | 18000443 | Cardinal HCG 4mL Kit | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
21 | 00810042681071 | 18000442 | 18000442 | ALERE HCG 4mL KIT | Pregnancy-Skreen | BIOCHEMICAL DIAGNOSTICS INC |
22 | 00804084000150 | GCS0104 | For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of b For use with IDEAL LIFE Gluco-Manager as a quality check to verify accuracy of blood glucose test results. The Control Solutions contains a known amount of glucose that reacts with the test strips. | IDEAL LIFE Control Solution Level II | IDEAL LIFE INC | |
23 | 00804084000143 | AGS-1112 | IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) | IDEAL LIFE INC | ||
24 | 00793150629794 | IGM-1003A | INFCN003L | Glucose Control Solution | Oh’Care Lite Glucose Control Solution | OSANG HEALTHCARE CO., LTD. |
25 | 00793150629763 | IGM-1003A | Blood Glucose Monitoring System Kit | Oh’Care Lite Blood Glucose Monitoring System Kit | OSANG HEALTHCARE CO., LTD. | |
26 | 00763924540105 | MD540 | Lipid and Glucose Measuring System | LipidPlus® Glucose Test Strips | JANT PHARMACAL CORPORATION | |
27 | 00748349000717 | 10001 | 10001 | Glucose Pilot - The Complete Glucose Monitoring System | Glucose Pilot | SYNTRON BIORESEARCH, INC. |
28 | 00742860100178 | 176 | 176 | OSOM H. Pylori Control Kit | SEKISUI DIAGNOSTICS, LLC | |
29 | 00742860100093 | 138 | 138 | HCG SERUM CONTROL KIT | SEKISUI DIAGNOSTICS, LLC | |
30 | 00732671109422 | 942-2 | 942-2 | Control Solution - L2 (High) | Pip | AMITY HOLDINGS, LLC |
31 | 00732671009425 | 942-1 | 942-1 | Control Solution - L1 (low) | Pip | AMITY HOLDINGS, LLC |
32 | 00732671009401 | 940 | 940 | Blood Glucose Test Meter | Pip | AMITY HOLDINGS, LLC |
33 | 00699073704320 | 70432 | 70432 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
34 | 00699073140029 | 14002 | 14002 | FreeStyle Control Solution | FreeStyle | ABBOTT DIABETES CARE INC |
35 | 00695684781026 | 78102 | AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStri AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStrip® HB Hemoglobin (Hb) Meter. | AIMSTRIP HEMOGLOBIN OPTICAL VERIFIERS | GERMAINE LABORATORIES, INC | |
36 | 00695684775124 | ILM-0001A | blood glucose meter and test strip control solution-level 1,2,3 | AimStrip Tandem Glucose control solution | OSANG HEALTHCARE CO., LTD. | |
37 | 00695684774127 | ILM-0001A | Lipid measuring meter and Triglycerides test strip control solution level 1,2 | AimStrip Tandem Total Triglycerides Control Solution | OSANG HEALTHCARE CO., LTD. | |
38 | 00695684773120 | ILM-0001A | Lipid measuring meter and Total Cholesterol test strip control solution level 1,2 | AimStrip Tandem Total Cholesterol Control Solution | OSANG HEALTHCARE CO., LTD. | |
39 | 00695684773014 | ILM-0001A | Lipid and Glucose Measuring System | AimStrip Tandem Lipid Profile and glucose measuring system | OSANG HEALTHCARE CO., LTD. | |
40 | 00695684373122 | 37312 | Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test St Blood glucose control solution for use with AimStrip® Plus Blood Glucose Test Strips & meter for testing blood glucose levels | AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION | GERMAINE LABORATORIES, INC | |
41 | 00695684131128 | 13112 | Ketone controls for use with ketone tests, 1 Positive and 1 Negative | KETONE SERUM CONTROLS | GERMAINE LABORATORIES, INC | |
42 | 00682607571017 | G117-108 | 757101 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Voice Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
43 | 00682607558315 | G125-12L | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Pro Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
44 | 00682607558117 | G115-107 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Pal Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
45 | 00682607557325 | G125-12D | Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 | On Call Express Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
46 | 00682607557158 | G115-10D | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
47 | 00682607556311 | G125-122 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Vivid Glucose Control Solution Kit | ACON LABORATORIES, INC. | |
48 | 00682607556113 | G115-102 | Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Vivid Blood Glucose Monitoring System | ACON LABORATORIES, INC. | |
49 | 00682607550128 | G115-10S | 755012 | Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) | On Call Express Mobile Blood Glucose Monitoring System | ACON LABORATORIES, INC. |
50 | 00682607535316 | G123-311 | Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2 | On Call Plus Glucose Control Solution Kit | ACON LABORATORIES, INC. |