| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00857969006709 | 404200-1 | 404200-1 | ACE Axcel Clinical Chemistry System with ISE | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ACE Axcel® |
| 2 | 00857969006600 | S2-87 | S2-87 | Hemoglobin A1c Calibrators | JIS | Calibrator, Primary | 2 | Alfa Wassermann |
| 3 | 00857969006433 | C2-87 | C2-87 | Lipid Controls | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alfa Wassermann |
| 4 | 00857969006426 | C2-86 | C2-86 | Hemoglobin A1c Controls | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Alfa Wassermann |
| 5 | 00857969006402 | C1-5 | C1-5 | Level 2 Chemistry Control | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alfa Wassermann |
| 6 | 00857969006396 | C1-4 | Level 1 Chemistry Control | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Alfa Wassermann | |
| 7 | 00857969006389 | SA1029 | SA1029 | CAL A | JIX | Calibrator, Multi-Analyte Mixture | 2 | Alfa Wassermann |
| 8 | 00857969006372 | E1-9 | E1-9 | STARLYTE V Fluid Pack | Alfa Wassermann | |||
| 9 | 00857969006327 | E1-3 | E1-3 | REFERENCE ELECTRODE SOLUTION | Alfa Wassermann | |||
| 10 | 00857969006310 | E1-2 | E1-2 | CAL B | Alfa Wassermann | |||
| 11 | 00857969006204 | S2-86 | S2-86 | Hemoglobin A1c Calibrators | JIS | Calibrator, Primary | 2 | Alfa Wassermann |
| 12 | 00857969006198 | S2-85 | S2-85 | Urine Standard | JIX | Calibrator, Multi-Analyte Mixture | 2 | Alfa Wassermann |
| 13 | 00857969006181 | S1-33 | S1-33 | GemCal Reference Serum | JIX | Calibrator, Multi-Analyte Mixture | 2 | Alfa Wassermann |
| 14 | 00857969006051 | 906178 | 906178 | Electrode, Chloride | CGZ | Electrode, Ion-Specific, Chloride | 2 | Alfa Wassermann |
| 15 | 00857969006044 | 903394 | 903394 | Electrode, Potassium | CEM | Electrode, Ion Specific, Potassium | 2 | Alfa Wassermann |
| 16 | 00857969006037 | 903393 | 903393 | Electrode, Sodium | JGS | Electrode, Ion Specific, Sodium | 2 | Alfa Wassermann |
| 17 | 00857969006693 | 402900-1 | 402900-1 | ACE Alera Clinical Chemistry System with ISE | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ACE Alera® |
| 18 | 00857969006587 | SA2019 | SA2019 | Magnesium Reagent | JGJ | Photometric Method, Magnesium | 1 | ACE |
| 19 | 00857969006594 | SA2038 | SA2038 | HDL-C Reagent | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | ACE |
| 20 | 00857969006686 | RX1053 | RX1053 | AST Reagent | CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | ACE |
| 21 | 00857969006679 | SA1053 | SA1053 | AST Reagent | CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 | ACE |
| 22 | 00857969006662 | SA1052 | SA1052 | ALT Reagent | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | ACE |
| 23 | 00857969006655 | SA1028 | SA1028 | ISE CLEANING AND SODIUM ELECTRODE CONDITIONER | ACE | |||
| 24 | 00857969006648 | SA1027 | SA1027 | ISE WASH | ACE | |||
| 25 | 00857969006631 | SA1021 | SA1021 | SYSTEM DILUENT | ACE | |||
| 26 | 00857969006624 | SA1020 | SA1020 | NORMAL SALINE DILUENT | ACE | |||
| 27 | 00857969006617 | SA1050 | SA1050 | Hemoglobin A1c Reagent | LCP | Assay, Glycosylated Hemoglobin | 2 | ACE |
| 28 | 00857969006570 | SA2016 | SA2016 | Inorganic Phosphorus U.V. Reagent | CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | ACE |
| 29 | 00857969006563 | SA2013 | SA2013 | γ-GT Reagent | JPZ | Colorimetric Method, Gamma-Glutamyl Transpeptidase | 1 | ACE |
| 30 | 00857969006556 | SA1046 | SA1046 | ALT Reagent | CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 | ACE |
| 31 | 00857969006549 | SA1045 | SA1045 | Lipase Reagent | CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 1 | ACE |
| 32 | 00857969006532 | SA1043 | SA1043 | HDL-C Reagent | LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | ACE |
| 33 | 00857969006525 | SA1040 | SA1040 | LDL-C Reagent | MRR | System, Test, Low Density, Lipoprotein | 1 | ACE |
| 34 | 00857969006518 | SA1025 | SA1025 | Uric Acid Reagent | KNK | Acid, Uric, Uricase (Colorimetric) | 1 | ACE |
| 35 | 00857969006501 | SA1023 | SA1023 | Triglycerides Reagent | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | ACE |
| 36 | 00857969006495 | SA1017 | SA1017 | Total Iron Reagent | JIY | Photometric Method, Iron (Non-Heme) | 1 | ACE |
| 37 | 00857969006488 | SA1010 | SA1010 | Cholesterol Reagent | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | ACE |
| 38 | 00857969006471 | RX1026 | RX1026 | LDL-C Reagent | MRR | System, Test, Low Density, Lipoprotein | 1 | ACE |
| 39 | 00857969006464 | RX1025 | RX1025 | Uric Acid Reagent | KNK | Acid, Uric, Uricase (Colorimetric) | 1 | ACE |
| 40 | 00857969006457 | RX1023 | RX1023 | Triglycerides Reagent | CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | ACE |
| 41 | 00857969006440 | RX1010 | RX1010 | Cholesterol Reagent | CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | ACE |
| 42 | 00857969006419 | C2-85 | C2-85 | Urine Chemistry Controls | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | ACE |
| 43 | 00857969006365 | E1-8 | E1-8 | Starlyte III Fluid Pack | ACE | |||
| 44 | 00857969006358 | E1-7 | E1-7 | Urine Diluent | ACE | |||
| 45 | 00857969006341 | E1-6 | E1-6 | Starlyte Sodium Electrode Conditioner | ACE | |||
| 46 | 00857969006334 | E1-5 | E1-5 | Starlyte Cleaning Solution | ACE | |||
| 47 | 00857969006303 | SA2002 | SA2002 | Alkaline Phosphatase Reagent | CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | ACE |
| 48 | 00857969006297 | RX2002 | RX2002 | Alkaline Phosphatase Reagent | CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | ACE |
| 49 | 00857969006280 | SA3018 | SA3018 | LDH-L Reagent | CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 | ACE |
| 50 | 00857969006266 | SA2024 | SA2024 | BUN / UREA Reagent | CDN | Urease, Photometric, Urea Nitrogen | 2 | ACE |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03573026156916 | 30404-01 | The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the d The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the determinat ion of human thyroxine (T4) concentration in serum or plasma (heparin). | VIDAS® T4 | BIOMERIEUX SA | |
| 2 | 00884883005655 | 100050 | CEDIA T4 Assay | MICROGENICS CORPORATION | ||
| 3 | 00884883004177 | 10013070 | DRI Thyroxine (T4) | MICROGENICS CORPORATION | ||
| 4 | 00884883003446 | 0454 | DRI Thyroxine (T4) | MICROGENICS CORPORATION | ||
| 5 | 00857969006273 | SA3007 | SA3007 | T4 Reagent | ACE | ALFA WASSERMANN, INC. |
| 6 | 00850392007077 | BC-1007 | BC-1007 | The BioCheck T4 EIA Test Kit is intended for the quantitative determination of t The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum. | BioCheck T4 EIA Test Kit | BIOCHECK, INC. |
| 7 | 00842768015434 | 10445101 | K6065 | Thyroxine Flex® reagent cartridge, 160 tests | Dimension Vista® Flex® reagent cartridge T4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 8 | 00842768005626 | 10444908 | DF65 | Thyroxine Flex® reagent cartridge, 120 tests | Dimension® Flex® reagent cartridge T4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 9 | 00840239041098 | EIA-4109 | EIA-4109 | The Quantitative Determination of Free Thyroxine Concentration in Human Serum or The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay. | Free Thyroxine (fT4) ELISA | DRG INTERNATIONAL INC |
| 10 | 00840239017819 | EIA-1781 | EIA-1781 | For the quantitative determination of total thyroxine (T4) concentration in huma For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. | Total Thyroxine (T4) ELISA | DRG INTERNATIONAL INC |
| 11 | 00811727013149 | T1007-96 | T1007-96 | T4 for the quantitative determination of the Total Thyroxine (T4) concentration T4 for the quantitative determination of the Total Thyroxine (T4) concentration in human serum. For in vitro diagnostic use only. 96 Test | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
| 12 | 00725609000649 | 85-4000-05K | 85-4000-05K | T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantit T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of Thyroxine (T4) Levels in Neonates | SPOTCHECK | ASTORIA-PACIFIC, INC. |
| 13 | 00630414972992 | 10381685 | L2KT42 | T4 Total - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems TT4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 14 | 00630414970110 | 10381635 | LKT45 | T4 Total - IMMULITE - RGT - 500 Tests | IMMULITE®/IMMULITE® 1000 Systems T4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 15 | 00630414966229 | 10381633 | LKT41 | T4 Total - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems T4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 16 | 00630414966038 | 10381664 | L2KT46 | T4 Total - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems TT4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 17 | 00630414954370 | 10387587 | LT4Z | Total T4 Sample Diluent - IMMULITE - CAL - 1x25mL | IMMULITE®/IMMULITE® 1000 Systems T4 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 18 | 00380740131524 | 07P9530 | 07P9530 | Alinity i Total T4 Reagent Kit 1200 Tests | Alinity | ABBOTT IRELAND |
| 19 | 00380740131517 | 07P9520 | 07P9520 | Alinity i Total T4 Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND |
| 20 | 00380740129507 | 7K66-37 | 07K6637 | ARCHITECT Total T4 Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
| 21 | 00380740129491 | 7K66-32 | 07K6632 | ARCHITECT Total T4 Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
| 22 | 00380740129484 | 7K66-27 | 07K6627 | ARCHITECT Total T4 Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
| 23 | 00380740129460 | 7K66-12 | 07K6612 | ARCHITECT Total T4 Controls | ARCHITECT | ABBOTT IRELAND |
| 24 | 00380740105952 | 7K66-35 | 07K6635 | ARCHITECT Total T4 Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
| 25 | 00380740014445 | 7K66-30 | 07K6630 | ARCHITECT Total T4 Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
| 26 | 00380740014438 | 7K66-25 | 07K6625 | ARCHITECT Total T4 Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
| 27 | 00380740014414 | 7K66-10 | 07K6610 | ARCHITECT Total T4 Controls | ARCHITECT | ABBOTT IRELAND |
| 28 | 00380740014407 | 7K66-01 | 07K6601 | ARCHITECT Total T4 Calibrators | ARCHITECT | ABBOTT IRELAND |
| 29 | B24225TT4HUE010 | 25-TT4HU-E01 | 25-TT4HU-E01 | The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitati The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. | Total Thyroxine ELISA (Total T4 ELISA) | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 30 | 15099590225742 | 33800 | 33800 | The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoass The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. | Access Total T4 | BECKMAN COULTER, INC. |
| 31 | 14560189210803 | N/A | ST AIA-PACK T4 | TOSOH CORPORATION | ||
| 32 | 10758750005147 | 8744468 | 8744468 | VITROS Immunodiagnostic Products Total T4 Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 33 | 06438147312139 | 3302-001U | 3302-001U | For the quantitative determination of thyroxine (T4) in dried blood. | GSP Neonatal Thyroxine (T4) kit | WALLAC OY |
| 34 | 04560189211803 | N/A | AIA-PACK T4 CALIBRATOR SET | TOSOH CORPORATION | ||
| 35 | 04560189211797 | N/A | AIA-PACK T4 SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
| 36 | 04015630916016 | 20739006322 | 20739006322 | Total T4 Thyroxine) | ROCHE DIAGNOSTICS GMBH |