| 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 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
| 46 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 47 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
| 48 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
| 49 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 50 | 10758750008742 | 1306026 | 1306026 | VITROS Immunodiagnostic ProductsTestosterone Calibrators | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | VITROS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 14560189210698 | N/A | ST AIA-PACK LH II | TOSOH CORPORATION | ||
| 2 | 10805360016039 | 15101 | OvuQuick Ovulation Predictor Test | VITROLIFE INC. | ||
| 3 | 10805360016015 | 15100 | OvuQuick Ovulation Predictor Test | VITROLIFE INC. | ||
| 4 | 10796918002157 | 02-2540-6 | INSTANT-VIEW LH Ovulation Predicting Midstream Cassette Test, 6 tests | INSTANT-VIEW LH Midstream Cassette Test, 6 tests | ALFA SCIENTIFIC DESIGNS, INC. | |
| 5 | 10796918000122 | 02-2547 | INSTANT-VIEW LH Ovulation Predicting Dip-Strip Test | INSTANT-VIEW LH Ovulation Predicting Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 6 | 10796918000115 | 02-2542 | INSTANT-VIEW LH Ovulation Predicting Cassette Test | INSTANT-VIEW LH Ovulation Predicting Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 7 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 8 | 10758750008384 | 1090133 | 1090133 | VITROS Immunodiagnostic ProductsLH Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 9 | 10743816000778 | OSH-143-35-01 | OSH-143-35-01 | OvuSign® LH card; 35 Test Kit; CE | OvuSign® LH card | PRINCETON BIOMEDITECH CORPORATION |
| 10 | 08719699634633 | FK-127-CO | FK-127A contains 50 ovulation test and 20 pregnancy tests. | iProven | SEVENGROUND TRADING B.V. | |
| 11 | 06438147009206 | A031-101 | A031-101 | Time-resolved fluoroimmunoassay for the quantitative determination of human lute Time-resolved fluoroimmunoassay for the quantitative determination of human luteinizing hormone (hLH). | DELFIA hLH Spec kit | WALLAC OY |
| 12 | 05400569000452 | KIP1311 | LHsp-IRMA | LHsp-IRMA | DIASOURCE IMMUNOASSAYS S.A. SA | |
| 13 | 04987270235270 | 235270 | Lumipulse G LH Immunoreaction Cartridges | FUJIREBIO INC. | ||
| 14 | 04560189211667 | N/A | AIA-PACK LH II SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
| 15 | 04560189211650 | N/A | ST AIA-PACK LH II CALIBRATOR SET | TOSOH CORPORATION | ||
| 16 | 04015630939749 | 07027575190 | 07027575190 | Elecsys LH | ROCHE DIAGNOSTICS GMBH | |
| 17 | 04015630907410 | 11732234122 | 11732234122 | Elecsys LH | ROCHE DIAGNOSTICS GMBH | |
| 18 | 03573026156930 | 30406-01 | VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS fam VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of LH concentration in human serum or plasma . | VIDAS® LH | BIOMERIEUX SA | |
| 19 | 00869220000326 | BDW2-S | The Babydust Method | BABYDUST METHOD LLC, THE | ||
| 20 | 00857275007551 | 21103015410508 | LH Ovulation Test Strip-3.5mm | PreKnow | IDUN SOLUTIONS LLC | |
| 21 | 00855944007369 | EZW-LH3C100 | 100 Disposable Plastic Urine Specimen Cups | Easy@Home Disposable Plastic Urine Cup (100- pack) | EASY HEALTHCARE CORPORATION | |
| 22 | 00855944007352 | EZW-LH3C50 | 50 Disposable Plastic Urine Specimen Cups | Easy@Home Disposable Plastic Urine Specimen Cups (50- pack) | EASY HEALTHCARE CORPORATION | |
| 23 | 00855944007338 | PM2-S,PM1-S | PMS-6020 | Premom 30 LH Ovulation Strips and 10 HCG Pregnancy Strips Kit (60 LH + 20 HCG) | Premom Ovulation Test Kit (60 LH + 20 HCG) | EASY HEALTHCARE CORPORATION |
| 24 | 00855944007192 | PM2-C, PM1-C | PMC-3010 | Premom 30 LH Ovulation Cassettes and 10 HCG Pregnancy Cassettes Kit (30 LH + 10 HCG) | Premom Ovulation Cassette Kit (30 LH + 10 HCG) | EASY HEALTHCARE CORPORATION |
| 25 | 00855944007178 | PM2-C | PMC-225 | Premom LH Ovulation Cassette (25 Pack of Individually-Sealed LH Urine Tests with Pipette) | Premom Ovulation Test Cassette (25 test kit) | EASY HEALTHCARE CORPORATION |
| 26 | 00855944007109 | EZW2-S | EZW2-S-15 | Easy@Home 15 Ovulation Test Strips | Easy@Home Ovulation Test Strip (15 tests kit) | EASY HEALTHCARE CORPORATION |
| 27 | 00855944007093 | EZW2-S | LH test strips in bulk package | Easy@Home Ovulation Test Strip (bulk) | EASY HEALTHCARE CORPORATION | |
| 28 | 00855944007086 | EZW2-M , EZW1-M | EZM1-L15H5 | Easy@Home 15 Ovulation (LH) and Plus 5 Pregnancy (hCG) Test Sticks | Easy@Home Ovulation Test Kit (15 LH Midstreams+5 HCG Midstreams) | EASY HEALTHCARE CORPORATION |
| 29 | 00855944007055 | EZW2-M , EZW1-M | EZM1-L10H2 | Easy@Home 10 Ovulation Test and 2 Pregnancy Test Sticks | Easy@Home Ovulation Test Kit (10 LH Midstreams+ 2 HCG Midstreams) | EASY HEALTHCARE CORPORATION |
| 30 | 00855944007024 | EZ-WS2525 | EZW2-S, EZW1-S | 25 LH strips + 25 HCG strips | Easy@Home Ovulation Test Kit (25 LH strips + 25 HCG strips ) | EASY HEALTHCARE CORPORATION |
| 31 | 00855944007017 | EZ-WS5050 | EZW2-S, EZW1-S | 50 LH strips + 50 HCG strips | Easy@Home Ovulation Test Kit (50 LH strips + 50 HCG strips ) | EASY HEALTHCARE CORPORATION |
| 32 | 00855606007089 | Combo Pack 7 Ovulation Tests + 1 Pregnancy Test | A convenience kit consisting of 7 One-step Ovulation Tests and 1 One-step Pregnancy Test | Up & Up | TARGET CORPORATION | |
| 33 | 00850253007864 | EZM1-L25 | EZW2-M | 25 tests kit; LH test midstreams | Easy@Home Ovulation Test Midstream (25 tests kit) | EASY HEALTHCARE CORPORATION |
| 34 | 00850253007857 | EZM1-L15 | EZW2-M | 15 tests kit; LH Midstreams | Easy@Home Ovulation Test Midstream (15 tests kit) | EASY HEALTHCARE CORPORATION |
| 35 | 00850253007833 | EZW2-S | 50 tests kit; LH test strips in bulk package | Easy@Home Ovulation Test Strip (50 tests-bulk pack) | EASY HEALTHCARE CORPORATION | |
| 36 | 00850253007727 | EZW2-S | 100 tests kit; LH strips | Easy@Home Ovulation Test (100 LH strips) | EASY HEALTHCARE CORPORATION | |
| 37 | 00850253007680 | EZM1-L8H2 | EZW2-M , EZW1-M | 8 LH midstreams + 2 HCG midstreams | Easy@Home Ovulation Test Kit (8 LH Midstreams+ 2 HCG Midstreams) | EASY HEALTHCARE CORPORATION |
| 38 | 00850253007666 | EZM2M3-L10H2 | EZW2-M , EZW1-M | 10 LH midstreams + 2 HCG midstreams | Easy@Home Ovulation Test Kit (10 LH Midstreams+ 2 HCG Midstreams) | EASY HEALTHCARE CORPORATION |
| 39 | 00850253007642 | EZ-WS155 | EZW2-S, EZW1-S | 15 LH strips + 5 HCG strips | Easy@Home Ovulation Test Kit (15 LH strips + 5 HCG strips ) | EASY HEALTHCARE CORPORATION |
| 40 | 00850253007635 | EZ-WS4010 | EZW2-S, EZW1-S | 40 LH strips + 10 HCG strips | Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips ) | EASY HEALTHCARE CORPORATION |
| 41 | 00850253007628 | EZ-WS10040 | EZW2-S, EZW1-S | 100 LH strips + 40 HCG strips | Easy@Home Ovulation Test Kit (100 LH strips + 40 HCG strips ) | EASY HEALTHCARE CORPORATION |
| 42 | 00850253007611 | EZ-WS5020 | EZW2-S, EZW1-S | 50 LH strips + 20 HCG strips | Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips ) | EASY HEALTHCARE CORPORATION |
| 43 | 00850253007284 | EZ-WS10020 | EZW2-S, EZW1-S | Easy@Home Ovulation Test kit (100 LH strips + 20 HCG strips ) | EASY HEALTHCARE CORPORATION | |
| 44 | 00850253007277 | EZW2-S-50 | EZW2-S | Easy@Home Ovulation Test Strip (50 tests kit) | EASY HEALTHCARE CORPORATION | |
| 45 | 00850253007260 | EZW2-S-25 | EZW2-S | Easy@Home Ovulation Test Strip (25 tests kit) | EASY HEALTHCARE CORPORATION | |
| 46 | 00842768026447 | 10488534 | K6461 | LOCI Luteinizing Hormone Flex® reagent cartridge, 200 tests | Dimension Vista® Flex® reagent cartridge LH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 47 | 00840239041036 | EIA-4103 | EIA-4103 | The Quantitative Determination of Luteinizing Hormone Concentration in Human Ser The Quantitative Determination of Luteinizing Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric. | LH ELISA | DRG INTERNATIONAL INC |
| 48 | 00829576076703 | Early Ovulation Test | A convenience kit consisting of 10 Ovulation Test devices and 1 One Step Pregnancy Test. | Up & Up | TARGET CORPORATION | |
| 49 | 00816870022635 | 675-300 | 675-300B | Monobind AccuLite LH CLIA Kit - 192 Wells | MONOBIND, INC. | |
| 50 | 00816870022628 | 675-300 | 675-300A | Monobind AccuLite LH CLIA Kit - 96 Wells | MONOBIND, INC. |