No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10758750034895 | 6177750 | 6177750 | VITROS Immunodiagnostic ProductsAFP Calibrators | JIS | Calibrator, primary | 2 | VITROS |
2 | 10758750034819 | 6177745 | 6177745 | VITROS Immunodiagnostic Products AFP Reagent Pack | LOJ | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER | 2 | VITROS |
3 | 10758750034659 | 6199330 | 6199330 | VITROS Immunodiagnostic ProductsProlactin Calibrators | JIS | Calibrator, primary | 2 | VITROS |
4 | 10758750034420 | 6199961 | 6199961 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
5 | 10758750034413 | 6199960 | 6199960 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
6 | 10758750034321 | 6199337 | 6199337 | VITROS Immunodiagnostic Products Prolactin Reagent Pack | CFT | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) | 1 | VITROS |
7 | 10758750034314 | 6199336 | 6199336 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | VITROS |
8 | 10758750033409 | 6199924 | 6199924 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls | QKO | Reagent, coronavirus serological | VITROS | |
9 | 10758750033393 | 6199923 | 6199923 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
10 | 10758750033386 | 6199922 | 6199922 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
11 | 10758750033379 | 6199921 | 6199921 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls | QKO | Reagent, coronavirus serological | VITROS | |
12 | 10758750033362 | 6199920 | 6199920 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
13 | 10758750033355 | 6199919 | 6199919 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
14 | 10758750033317 | 6192256 | 6192256 | VITROS Immunodiagnostic Products NT-proBNP II Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
15 | 10758750033300 | 6192255 | 6192255 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | NBC | Test, natriuretic peptide | 2 | VITROS |
16 | 10758750033294 | 6195575 | 6195575 | VITROS Immunodiagnostic Products BRAHMS PCT Calibrator | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
17 | 10758750033287 | 6197735 | 6197735 | VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
18 | 10758750033195 | 691 2265 | 691 2265 | VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
19 | 10758750033171 | 691 2263 | 691 2263 | VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
20 | 10758750033164 | 691 2261 | 691 2261 | VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
21 | 10758750032945 | 6905561 | 6905561 | VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
22 | 10758750032938 | 6905560 | 6905560 | VITROS Immunodiagnostic Products BRAHMS PCT Controls | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
23 | 10758750032068 | 6844425 | 6844425 | VITROS Immunodiagnostic Products Insulin Reagent Pack | CFP | RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN | 1 | VITROS |
24 | 10758750032051 | 6844424 | 6844424 | VITROS Immunodiagnostic Products C-peptide Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
25 | 10758750032044 | 6844426 | 6844426 | VITROS Immunodiagnostic Products Insulin Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
26 | 10758750032037 | 6844423 | 6844423 | VITROS Immunodiagnostic Products C-peptide Reagent Pack | JKD | RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN | 1 | VITROS |
27 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | MZF | Test, hiv detection | 2 | VITROS |
28 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | MZF | Test, hiv detection | 2 | VITROS |
29 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | VITROS |
30 | 10758750030200 | 6844055 | 6844055 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
31 | 10758750009541 | 1681543 | 1681543 | VITROS Immunodiagnostic Products Cortisol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
32 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
33 | 10758750009404 | 1614965 | 1614965 | VITROS Immunodiagnostic Products Total T3 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
34 | 10758750009367 | 1540525 | 1540525 | VITROS Immunodiagnostic Products Vitamin B12 Calibrators | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
35 | 10758750009237 | 1513266 | 1513266 | VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | VITROS |
36 | 10758750009213 | 1487289 | 1487289 | VITROS Immunodiagnostic Products TSH Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
37 | 10758750009145 | 1471481 | 1471481 | VITROS Immunodiagnostic Products T3 Uptake Reagent Pack | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | 2 | VITROS |
38 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
39 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | VITROS |
40 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
41 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
42 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
43 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | CEC | RADIOIMMUNOASSAY, FREE THYROXINE | 2 | VITROS |
44 | 10758750008926 | 1372101 | 1372101 | VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator | LOL | Hepatitis a test (antibody and igm antibody) | 2 | VITROS |
45 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 1 | VITROS |
46 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
47 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
48 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
49 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
50 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10385542013013 | 8000-02013 | Control Solution, AgaMatrix, High | AgaMatrix | AGAMATRIX, INC. | |
2 | 10385541335017 | 8000-01335 | Control Solution, AgaMatrix, Normal | AgaMatrix | AGAMATRIX, INC. | |
3 | 10385541003503 | 8000-10520 | Control Solution, AgaMatrix, Level 4 | AgaMatrix | AGAMATRIX, INC. | |
4 | 10385541003305 | 8000-10519 | Control Solution, AgaMatrix, Level 2 | AgaMatrix | AGAMATRIX, INC. | |
5 | 10301937315012 | 7315 | 7315 | Control Solution - Level 1. 1 x 2.5 mL. | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. |
6 | 10301937314015 | 7314 | 7314 | Control Solution - Level 2. 1 x 2.5 mL. | CONTOUR® NEXT | ASCENSIA DIABETES CARE US INC. |
7 | 10301937111010 | 7111B | 7111B | Control Solution - High, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
8 | 10301937110013 | 7110B | 7110B | Control Solution - Low, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
9 | 10301937109017 | 7109B | 7109B | Control Solution - Normal, 1 x 2.5 mL | CONTOUR® | ASCENSIA DIABETES CARE US INC. |
10 | 10301931491019 | 1491A | 1491A | Control Solution - High, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
11 | 10301931490012 | 1490A | 1490A | Control Solution - Low, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
12 | 10301931489016 | 1489A | 1489A | Control Solution - Normal, 1 x 2.5 mL | BREEZE® 2 | ASCENSIA DIABETES CARE US INC. |
13 | M52551390 | 5139 | Alkaline Phosphatase Isoenzyme Control (1 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
14 | M52551040 | 5104 | Gel Alk Phosphatase Isoenzyme Control (1 x 2 mL) | HELENA LABORATORIES CORPORATION | ||
15 | M52532180 | 3218 | REP Cholesterol Profile Control (5 x 1 mL) | HELENA LABORATORIES CORPORATION | ||
16 | 10052569138479 | TRUEtrack PRE-PACK | A4089-75 | Health Mart PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
17 | 10021292008625 | TRUEtrack PRE-PACK | A4027-75 | Preferred Plus Pharmacy TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
18 | 10021292008618 | TRUEtrack PRE-PACK | A4011-75 | GOOD NEIGHBOR PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
19 | 10021292006874 | TRUEtrack PRE-PACK | A4088-75 | HealthWise PHARMACY TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
20 | 10021292006867 | TRUEtrack PRE-PACK | A4054-75 | Sunmark TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
21 | 10021292006843 | TRUEtrack PRE-PACK | A4H01-75 | TRUEtrack PRE-PACK | TRUEtrack | TRIVIDIA HEALTH, INC. |
22 | 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 |
23 | 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 | |
24 | 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 | |
25 | 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 | |
26 | 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 | |
27 | 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 | |
28 | 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. |
29 | 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. |
30 | 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. |
31 | 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. |
32 | 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. |
33 | 08809301168073 | GT-C03 | GlucoTrack Solution Level 3 | PHILOSYS CO., LTD | ||
34 | 08809301168066 | GT-C02 | GlucoTrack Solution Level 2 | PHILOSYS CO., LTD | ||
35 | 08809301168059 | GT-C01 | GlucoTrack Solution Level 1 | PHILOSYS CO., LTD | ||
36 | 08809301162217 | PC003-US | Pip Control Solution High | PHILOSYS CO., LTD | ||
37 | 08809301162200 | PC002-US | Pip Control Solution Normal | PHILOSYS CO., LTD | ||
38 | 08809301162194 | PC001-US | Pip Control Solution Low | PHILOSYS CO., LTD | ||
39 | 08809301162057 | PC-001 | Gmate® Control Solution Level 1 | PHILOSYS CO., LTD | ||
40 | 08809301162026 | PC-003 | Gmate® Control Solution Level 3 | PHILOSYS CO., LTD | ||
41 | 08809301162019 | PC-002 | Gmate® Control Solution Level 2 | PHILOSYS CO., LTD | ||
42 | 08809115908971 | IGM-0021B | Blood Glucose Monitoring System | Element™Plus Meter | OSANG HEALTHCARE CO., LTD. | |
43 | 08809115908452 | IGM-0021B | Blood Glucose Monitoring System | Element™ Meter | OSANG HEALTHCARE CO., LTD. | |
44 | 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. | |
45 | 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. | |
46 | 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. | |
47 | 08806679002718 | CFPC-15 | CFPC-15 | ichroma™ iFOB | BODITECH MED INC. | |
48 | 08806128340064 | AGM-4000 | Embrace Pro Blood Glucose Test Meter | ALL MEDICUS CO.,LTD. | ||
49 | 08806128340019 | AGM-4000 | Embrace Pro Blood Glucose Test Strip | ALL MEDICUS CO.,LTD. | ||
50 | 08806128340002 | AGM-4000 | Embrace Pro Control Solution | ALL MEDICUS CO.,LTD. |