| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 14560189212463 | N/A | LCP | Assay, Glycosylated Hemoglobin | ST AIA-PACK HbA1c | |||
| 2 | 14560189212135 | N/A | KHQ | Radioassay, Triiodothyronine Uptake | ST AIA-PACK T-U | |||
| 3 | 14560189212005 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK RBC FOLATE | |||
| 4 | 04560189211827 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | AIA-PACK PRL CALIBRATOR SET | ||
| 5 | 04560189211407 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI CALIBRATOR SET | ||
| 6 | 04560189211292 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Sample Diluting Solution | ||
| 7 | 04560189212299 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK bHCG Calibration Verification Test Set | ||
| 8 | 04560189212022 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK RBC FOLATE HEMOLYZING REAGENT SET | ||
| 9 | 14560189212739 | N/A | CHP | Radioimmunoassay, Estradiol | ST AIA-PACK hsE2 | |||
| 10 | 14560189212517 | N/A | CKG | Radioimmunoassay, Acth | ST AIA-PACK ACTH | |||
| 11 | 14560189212104 | n/a | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | ST AIA-PACK PA | |||
| 12 | 14560189211916 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK Folate | |||
| 13 | 04560189211940 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK Floate Sample Diluting Solution | ||
| 14 | 14560189211879 | N/A | CDD | Radioassay, Vitamin B12 | AIA-PACK B12 | |||
| 15 | 04560189211889 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Calibrator Set | ||
| 16 | 04560189211650 | N/A | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | ST AIA-PACK LH II CALIBRATOR SET | ||
| 17 | 04560189211445 | N/A | CFL | Radioimmunoassay, Human Growth Hormone | 1 | AIA-PACK HGH Calibrator Set | ||
| 18 | 04560189211391 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | ||
| 19 | 04560189211308 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Calibrator Set | ||
| 20 | 14560189210834 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | ST AIA-PACK PRL | |||
| 21 | 14560189210483 | N/A | DBF | Ferritin, Antigen, Antiserum, Control | ST AIA-PACK FER | |||
| 22 | 14560189210391 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | ST AIA-PACK FSH | |||
| 23 | 14560189210360 | N/A | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | ST AIA-PACK TSH | ||
| 24 | 14560189210285 | N/A | CDP | Radioimmunoassay, Total Triiodothyronine | ST AIA-PACK FT3 | |||
| 25 | 14560189210117 | N/A | MMI | Immunoassay Method, Troponin Subunit | ST AIA-PACK cTnI 2 | |||
| 26 | 04560189212817 | N/A | LPS | Urinary Homocystine (Nonquantitative) Test System | 2 | ST AIA-PACK Homocysteine Pretreatment Set | ||
| 27 | 04560189212800 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK Homocysteine Control Set | ||
| 28 | 04560189212596 | N/A | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | ST AIA-PACK DHEA-S Sample Diluting Solution | ||
| 29 | 04560189212190 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Cystatin C Calibatator Set | ||
| 30 | 04560189211285 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | ST AIA-PACK E2 CALIBRATOR SET | ||
| 31 | 04560189211278 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | AIA-PACK E2 Sample Diluting Solution | ||
| 32 | 04560189211148 | N/A | LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | AIA-PACK CA 125 Calibrator Set | ||
| 33 | 04560189211124 | N/A | NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pa System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | AIA-PACK CA 19-9 Sample Diluting Solution | ||
| 34 | 04560189211100 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | 2 | AIA-PACK 27.29 Calibrator Set | ||
| 35 | 14560189212173 | N/A | NDY | Test, Cystatin C | ST AIA-PACK Cystatin C | |||
| 36 | 04560189211902 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Sample Diluting Solution | ||
| 37 | 04560189211780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | 2 | AIA-PACK CEA Sample Diluting Solution | ||
| 38 | 04560189211421 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Intact PTH CALIBRATOR SET | ||
| 39 | 04560189211414 | N/A | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION | ||
| 40 | 04560189211353 | N/A | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | AIA-PACK βHCG Calibrator Set | ||
| 41 | 14560189210780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | ST AIA-PACK CEA | |||
| 42 | 14560189213125 | N/A | MRG | System, Test, Vitamin D | ST AIA-PACK 25-OH Vitamin D | |||
| 43 | 14560189210179 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | ST AIA-PACK 27.29 | |||
| 44 | 14560189210155 | N/A | DGC | Ige, Antigen, Antiserum, Control | ST AIA-PACK IgEII | |||
| 45 | 04560189284005 | N/A | KHO | Fluorometer, For Clinical Use | 1 | 9tray Sorter | ||
| 46 | 04560189283992 | AIA-900 | KHO | Fluorometer, For Clinical Use | 1 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | ||
| 47 | 04560189283619 | N/A | LCP | Assay, Glycosylated Hemoglobin | 2 | G8 Variant Elution Buffer HSi No.2 (S) | ||
| 48 | 04560189213395 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK PROG II CALIBRATOR SET | ||
| 49 | 04560189213371 | N/A | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | ||
| 50 | 04560189213333 | N/A | JIT | Calibrator, Secondary | 2 | AIA-PACK C-Peptide II Calibrator Set |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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. |
| 2 | 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. |
| 3 | 14560189210803 | N/A | ST AIA-PACK T4 | TOSOH CORPORATION | ||
| 4 | 10758750005147 | 8744468 | 8744468 | VITROS Immunodiagnostic Products Total T4 Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 5 | 06438147312139 | 3302-001U | 3302-001U | For the quantitative determination of thyroxine (T4) in dried blood. | GSP Neonatal Thyroxine (T4) kit | WALLAC OY |
| 6 | 04560189211803 | N/A | AIA-PACK T4 CALIBRATOR SET | TOSOH CORPORATION | ||
| 7 | 04560189211797 | N/A | AIA-PACK T4 SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
| 8 | 04015630916016 | 20739006322 | 20739006322 | Total T4 Thyroxine) | ROCHE DIAGNOSTICS GMBH | |
| 9 | 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 | |
| 10 | 00884883005655 | 100050 | CEDIA T4 Assay | MICROGENICS CORPORATION | ||
| 11 | 00884883004177 | 10013070 | DRI Thyroxine (T4) | MICROGENICS CORPORATION | ||
| 12 | 00884883003446 | 0454 | DRI Thyroxine (T4) | MICROGENICS CORPORATION | ||
| 13 | 00857969006273 | SA3007 | SA3007 | T4 Reagent | ACE | ALFA WASSERMANN, INC. |
| 14 | 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. |
| 15 | 00842768015434 | 10445101 | K6065 | Thyroxine Flex® reagent cartridge, 160 tests | Dimension Vista® Flex® reagent cartridge T4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 16 | 00842768005626 | 10444908 | DF65 | Thyroxine Flex® reagent cartridge, 120 tests | Dimension® Flex® reagent cartridge T4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 17 | 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 |
| 18 | 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 |
| 19 | 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. |
| 20 | 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. |
| 21 | 00630414972992 | 10381685 | L2KT42 | T4 Total - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems TT4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 22 | 00630414970110 | 10381635 | LKT45 | T4 Total - IMMULITE - RGT - 500 Tests | IMMULITE®/IMMULITE® 1000 Systems T4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 23 | 00630414966229 | 10381633 | LKT41 | T4 Total - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems T4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 24 | 00630414966038 | 10381664 | L2KT46 | T4 Total - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems TT4 Total T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 25 | 00630414954370 | 10387587 | LT4Z | Total T4 Sample Diluent - IMMULITE - CAL - 1x25mL | IMMULITE®/IMMULITE® 1000 Systems T4 Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 26 | 00380740131524 | 07P9530 | 07P9530 | Alinity i Total T4 Reagent Kit 1200 Tests | Alinity | ABBOTT IRELAND |
| 27 | 00380740131517 | 07P9520 | 07P9520 | Alinity i Total T4 Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND |
| 28 | 00380740129507 | 7K66-37 | 07K6637 | ARCHITECT Total T4 Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
| 29 | 00380740129491 | 7K66-32 | 07K6632 | ARCHITECT Total T4 Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
| 30 | 00380740129484 | 7K66-27 | 07K6627 | ARCHITECT Total T4 Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
| 31 | 00380740129460 | 7K66-12 | 07K6612 | ARCHITECT Total T4 Controls | ARCHITECT | ABBOTT IRELAND |
| 32 | 00380740105952 | 7K66-35 | 07K6635 | ARCHITECT Total T4 Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
| 33 | 00380740014445 | 7K66-30 | 07K6630 | ARCHITECT Total T4 Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
| 34 | 00380740014438 | 7K66-25 | 07K6625 | ARCHITECT Total T4 Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
| 35 | 00380740014414 | 7K66-10 | 07K6610 | ARCHITECT Total T4 Controls | ARCHITECT | ABBOTT IRELAND |
| 36 | 00380740014407 | 7K66-01 | 07K6601 | ARCHITECT Total T4 Calibrators | ARCHITECT | ABBOTT IRELAND |