No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850004812242 | 702013 | 702013 | Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Contr Kova poc, Pregnancy-Skreen hcG Liquid Control Urine, Negative and Positive Control, 5mL Kitbox | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen |
2 | 00810042683181 | 702012 | 702012 | HCG URINE CONTROL Negative/Low Positive 2x4mL KITBOX | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen |
3 | 00810042683174 | 18003155 | hCG Low Positive/Negative Urine 2x5mL Kitbox | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
4 | 00810042683143 | CD-DOACTLS10 | CD-DOACTLS10 | DOA Liquid Control Urine (2x10mL Kitbox) | DIF | Drug Mixture Control Materials | 1 | Clarity Diagnostics |
5 | 00810042682900 | Custom QC31 | PREGNANCY SKREEN Custom hCG Serum 4mL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
6 | 00810042682894 | Custom QC30 | PREGNANCY SKREEN Custom hCG Serum 5mL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
7 | 00810042682672 | 55700 | 55700 | Alcoscreen 2x4mL kitbox | DIF | Drug Mixture Control Materials | 1 | Alco-Screen |
8 | 00810042681415 | Custom QC25 | PREGNANCY SKREEN Custom hCG Liquid Urine 50mL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
9 | 00810042681408 | Custom QC24 | PREGNANCY SKREEN Custom hCG Liquid Urine 20mL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
10 | 00810042681392 | Custom QC23 | PREGNANCY SKREEN Custom hCG Liquid Urine 5mL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
11 | 00810042681385 | Custom QC22 | PREGNANCY SKREEN Custom hCG Liquid Urine 2mL | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
12 | 00810042681347 | Custom QC18 | PREGNANCY SKREEN Custom hCG Liquid Urine 4cc kit | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen | |
13 | 00810042681156 | 18030367 | 18030367 | HCG Urine 2x4mL dropper Kit | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Pregnancy-Skreen |
14 | 00810042681095 | 18000656 | 18000656 | CONSULT HCG 4mL KIT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Pregnancy-Skreen | |
15 | 00810042681088 | 18000443 | 18000443 | Cardinal HCG 4mL Kit | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Pregnancy-Skreen | |
16 | 00810042681071 | 18000442 | 18000442 | ALERE HCG 4mL KIT | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Pregnancy-Skreen | |
17 | 00810042682696 | 21000 | 210000 | STATUS DS Positive Control 5mL | DIF | Drug Mixture Control Materials | 1 | Life Sign |
18 | 00810042682689 | 21000 | 210000 | STATUS DS Negative Control 5mL | DIF | Drug Mixture Control Materials | 1 | Life Sign |
19 | 00810042682399 | 35071377 | 35071377 | VMA-SKREEN COLUMNS Pk.500 | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
20 | 00810042682382 | 35071351 | 35071351 | VMA-SKREEN COLUMNS, Pk.50 | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
21 | 00810042682351 | 35072004 | 35072004 | WASHING SOLUTION, 2.75L | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
22 | 00810042682344 | 35071954 | 35071954 | VMA BUFFER, pH 2.0, 1L | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
23 | 00810042682337 | 35071903 | 35071903 | VMA BUFFER, pH 2.0,100mL | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
24 | 00810042682320 | 35071806 | 35071806 | VMA STANDARD, 6mg | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
25 | 00810042682313 | 35071709 | 35071709 | Tetrabutylammonium Hydroxide 25% 12mL | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
26 | 00810042682306 | 35071601 | 35071601 | DIAZO REAGENT,15mg | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
27 | 00810042682290 | 35071555 | 35071555 | SODIUM CARBONATE REAGENT 10%, 525mL | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
28 | 00810042682283 | 35071504 | 35071504 | SODIUM CARBONATE REAGENT 10%, 60mL | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
29 | 00810042682276 | 35071407 | 35071407 | WASHING SOLUTION 550mL | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
30 | 00810042682269 | 35071253 | 35071253 | ACETIC ACID, 60mL | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
31 | 00810042682252 | 35071202 | 35071202 | ACETIC ACID, 12 mL | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
32 | 00810042682245 | 35071156 | 35071156 | ETHYL ACETATE, 3.8L | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
33 | 00810042682238 | 35071105 | 35071105 | ETHYL ACETATE,1.2L | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
34 | 00810042682221 | 35071059 | 35071059 | SODIUM CHLORIDE, 1 KG | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
35 | 00810042682214 | 35071008 | 35071008 | SODIUM CHLORIDE, 90g | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
36 | 00810042682207 | 35070001 | 35070001 | VMA SKREEN KIT, 50 Determinations | CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 1 | VMA-SKREEN |
37 | 00810042681583 | 88010 | 88010 | Alere Professional cup 10mL kitbox | DIF | Drug Mixture Control Materials | 1 | Alere |
38 | 00810042681620 | 88005 | 88005 | iScreen 20mL KITBOX | DIF | Drug Mixture Control Materials | 1 | Alere |
39 | 00810042681576 | 88004 | 88004 | Alere iScreen 5mL KITBOX | DIF | Drug Mixture Control Materials | 1 | Alere |
40 | 00810042681569 | 88003 | 88003 | iScreen Positive 20mL | DIF | Drug Mixture Control Materials | 1 | Alere |
41 | 00810042681552 | 88002 | 88002 | iScreen Negative 20mL | DIF | Drug Mixture Control Materials | 1 | Alere |
42 | 00810042681545 | 88001 | 88001 | iScreen Positive, 5mL | DIF | Drug Mixture Control Materials | 1 | Alere |
43 | 00810042681538 | 88000 | 88000 | iScreen Negative 5mL | DIF | Drug Mixture Control Materials | 1 | Alere |
44 | 00810042681453 | 20200011 | 20200011 | ORAL FLUID NEGATIVE, 20mL | DIF | Drug Mixture Control Materials | 1 | Salivabuse |
45 | 00810042681446 | 20200001 | 20200001 | ORAL FLUID NEGATIVE, 5mL | DIF | Drug Mixture Control Materials | 1 | Salivabuse |
46 | 00810042681286 | Custom QC12 | Salivabuse Custom Liquid Control Oral Fluid 20mL | DIF | Drug Mixture Control Materials | 1 | Salivabuse | |
47 | 00810042681279 | Custom QC11 | Salivabuse Custom Liquid Control Oral Fluid 5mL | DIF | Drug Mixture Control Materials | 1 | Salivabuse | |
48 | 00810042681163 | 55700 | 55700 | Alco-screen Oral Fluid kitbox,4mL | DIF | Drug Mixture Control Materials | 1 | Salivabuse |
49 | 00810042681149 | 18100151 | 18100151 | CP-OF Panel, 3X, 20mL | DIF | Drug Mixture Control Materials | 1 | Salivabuse |
50 | 00810042681132 | 18100150 | 18100150 | CP-OF Panel, +50%, 20mL | DIF | Drug Mixture Control Materials | 1 | Salivabuse |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10301937315012 | 7315 | 7315 | Control Solution - Level 1. 1 x 2.5 mL. | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. |
2 | 10301937314015 | 7314 | 7314 | Control Solution - Level 2. 1 x 2.5 mL. | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. |
3 | 10301937111010 | 7111B | 7111B | Control Solution - High, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
4 | 10301937110013 | 7110B | 7110B | Control Solution - Low, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
5 | 10301937109017 | 7109B | 7109B | Control Solution - Normal, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
6 | 10301931491019 | 1491A | 1491A | Control Solution - High, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
7 | 10301931490012 | 1490A | 1490A | Control Solution - Low, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
8 | 10301931489016 | 1489A | 1489A | Control Solution - Normal, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
9 | M52551390 | 5139 | Alkaline Phosphatase Isoenzyme Control (1 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
10 | M52551040 | 5104 | Gel Alk Phosphatase Isoenzyme Control (1 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
11 | M52532180 | 3218 | REP Cholesterol Profile Control (5 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
12 | 10052569138479 | TRUEtrack PRE-PACK | A4089-75 | Health Mart PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
13 | 10021292008625 | TRUEtrack PRE-PACK | A4027-75 | Preferred Plus Pharmacy TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
14 | 10021292008618 | TRUEtrack PRE-PACK | A4011-75 | GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
15 | 10021292006874 | TRUEtrack PRE-PACK | A4088-75 | HealthWise PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
16 | 10021292006867 | TRUEtrack PRE-PACK | A4054-75 | Sunmark TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
17 | 10021292006843 | TRUEtrack PRE-PACK | A4H01-75 | TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
18 | 09421902348112 | 107253 | HB510Ar | The lypholised Hemoglobin A1c Linearity controls are prepared from human blood a The lypholised Hemoglobin A1c Linearity controls are prepared from human blood and contain normal hemoglobin, preservatives and stabilizers. The controls are formulated to give enhanced stability.The Lyophilized Hemoglobin A1c Linearity Controls are intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols setup within individual clinical laboratories. | ExtendSure | CANTERBURY SCIENTIFIC LIMITED |
19 | 09421902348099 | B12397 | The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and leve The liquid Hemoglobin A1c Control kit contains 12 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
20 | 09421902348082 | HB510 | The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, The lypholised Hemoglobin A1c Linearity kit contains 1 vial each of level 1, 2, 3, 4 and 5 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
21 | 09421902348075 | HB710SBAr | The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and l The lypholised Hemoglobin A1c Control kit contains 4 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
22 | 09421902348068 | 220232 | Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reco Hemoglobin A1c Controls Levels 1 and 2, 4 vials of Level 1 Controls (0.25mL reconstituted), 4 Vials of Level 2 Controls (0.25mL reconstituted), 1 Package Insert | TOSOH | CANTERBURY SCIENTIFIC LIMITED | |
23 | 09421902348006 | B12396 | The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures. | ExtendSURE | CANTERBURY SCIENTIFIC LIMITED | |
24 | 08809317540566 | FREND Vitamin D Linearity Kit | FLK-VTD | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
25 | 08809317540559 | FREND TSH Linearity Kit | FLK-TSH | FREND™ TSH Linearity Kit is intended for use as an assayed linearity material fo FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
26 | 08809317540542 | FREND Testosterone Linearity Kit | FLK-TES | FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity ma FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Testosterone Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution | FREND | NANOENTEK, INC. |
27 | 08809317540535 | FREND PSA Plus Linearity Kit | FLK-PSA | FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity materi FREND™ PSA Plus Linearity Kit is intended for use as an assayed linearity material for the prostate-specific antigen (PSA) on the FREND™ System. The Linearity kit is for the FREND™ System only.FREND™ PSA Plus Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
28 | 08809317540528 | FREND Free T4 Linearity Kit | FLK-FT4 | FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity materia FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only.FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution. | FREND | NANOENTEK, INC. |
29 | 08809301168073 | GT-C03 | GlucoTrack Solution Level 3 | PHILOSYS CO., LTD | ||
30 | 08809301168066 | GT-C02 | GlucoTrack Solution Level 2 | PHILOSYS CO., LTD | ||
31 | 08809301168059 | GT-C01 | GlucoTrack Solution Level 1 | PHILOSYS CO., LTD | ||
32 | 08809301162217 | PC003-US | Pip Control Solution High | PHILOSYS CO., LTD | ||
33 | 08809301162200 | PC002-US | Pip Control Solution Normal | PHILOSYS CO., LTD | ||
34 | 08809301162194 | PC001-US | Pip Control Solution Low | PHILOSYS CO., LTD | ||
35 | 08809301162057 | PC-001 | Gmate® Control Solution Level 1 | PHILOSYS CO., LTD | ||
36 | 08809301162026 | PC-003 | Gmate® Control Solution Level 3 | PHILOSYS CO., LTD | ||
37 | 08809301162019 | PC-002 | Gmate® Control Solution Level 2 | PHILOSYS CO., LTD | ||
38 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Meter | OSANG HEALTHCARE CO., LTD. | |
39 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | Element™ Meter | OSANG HEALTHCARE CO., LTD. | |
40 | 08809115906533 | IGM-1003F | blood glucose meter and test strip control solution-level 3 | Oh'Care Lite Smart Glucose control solution-Level 3 | OSANG HEALTHCARE CO., LTD. | |
41 | 08809115906526 | IGM-1003F | blood glucose meter and test strip control solution-Level 2 | Oh'Care Lite Smart Glucose control solution-Level 2 | OSANG HEALTHCARE CO., LTD. | |
42 | 08809115906519 | IGM-1003F | blood glucose meter and test strip control solution level 1 | Oh'Care Lite Smart Glucose control solution-Level 1 | OSANG HEALTHCARE CO., LTD. | |
43 | 08806679002718 | CFPC-15 | CFPC-15 | ichroma™ iFOB | BODITECH MED INC. | |
44 | 08806128340064 | AGM-4000 | Embrace Pro Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
45 | 08806128340019 | AGM-4000 | Embrace Pro Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. | ||
46 | 08806128340002 | AGM-4000 | Embrace Pro Control Solution | ALL MEDICUS CO.,LTD. | ||
47 | 08718734961406 | 025.000.005 | GlucoLin is an assayed glucose control intended for professional use in the veri GlucoLin is an assayed glucose control intended for professional use in the verification of the linearity of the HemoCue® Glucose systems.A box of GlucoLin contains 5 levels of control material:GlucoLin XLow: 08718734961352GlucoLin Low: 08718734961369GlucoLin Normal: 08718734961376GlucoLin High: 08718734961383GlucoLin XHigh: 08718734961390 | GlucoLin | EUROTROL B.V. | |
48 | 08718734960935 | 180.013.002 | Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional us Eurotrol GlucoTrol-AQ is an assayed glucose control intended for professional use in the verification of the precision and accuracy of the HemoCue Glucose 201 analyzer.A box of Eurotrol GlucoTrol-AQ contains 2 levels of control material:GlucoTrol-AQ Low (1): 08718734961536GlucoTrol-AQ High (3): 08718734961543 | Eurotrol GlucoTrol-AQ | EUROTROL B.V. | |
49 | 08718734960645 | AlbuTrol Level 2 | 189.002.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |
50 | 08718734960621 | AlbuTrol Level 1 | 189.001.002 | Eurotrol AlbuTrol® is an assayed albumin control intended for professional use i Eurotrol AlbuTrol® is an assayed albumin control intended for professional use in the verification of the precision and accuracy of the HemoCue® Albumin 201 system. Eurotrol AlbuTrol® is intended for the quantitative determination of albumin. | Eurotrol AlbuTrol | EUROTROL B.V. |