No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10758750007455 | 6901939 | 6901939 | Anti-D BIOCLONE 3x10ml | BIOCLONE | |||
2 | 10758750007448 | 6901935 | 6901935 | Anti-B BIOCLONE 3x10ml | BIOCLONE | |||
3 | 10758750007431 | 6901934 | 6901934 | Anti-A BIOCLONE 3x10ml | BIOCLONE | |||
4 | 10758750004140 | 721380 | 721380 | Anti-Jka (Monoclonal) BioClone | BIOCLONE | |||
5 | 10758750005901 | MTS080212 | MTS080212 | MTS Anti-E (Monoclonal) Card | MTS | |||
6 | 10758750003570 | 716540 | 716540 | C3B C3D BIOCLONE 1X3ML | BIOCLONE | |||
7 | 10758750004157 | 721480 | 721480 | Anti-Jkb (Monoclonal) BioClone | BIOCLONE | |||
8 | 10758750003662 | 717380 | 717380 | ANTI-D BIOCLONE 15X10ML | BIOCLONE | |||
9 | 10758750003624 | 716980 | 716980 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML Green | BIOCLONE | |||
10 | 10758750003600 | 716910 | 716910 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green | BIOCLONE | |||
11 | 10758750003563 | 716530 | 716530 | ANTI-C3D BIOCLONE 1X3ML | BIOCLONE | |||
12 | 10758750003471 | 716080 | 716080 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML | BIOCLONE | |||
13 | 10758750003457 | 716000 | 716000 | Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML | BIOCLONE | |||
14 | 10758750003396 | 715380 | 715380 | ANTI-LEB (LE2) (MURINE MONOCLONAL) BIOCLONE 2.0 | BIOCLONE | |||
15 | 10758750003389 | 715280 | 715280 | ANTI-LEA (LE1) (MURINE MONOCLONAL) BIOCLONE 2.0 | BIOCLONE | |||
16 | 10758750003297 | 714180 | 714180 | ANTI-SMALL E (ANTI-RH5) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
17 | 10758750003266 | 714080 | 714080 | ANTI-SMALL C (ANTI-RH4) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
18 | 10758750003259 | 713180 | 713180 | ANTI-E (ANTI-RH3) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
19 | 10758750003198 | 713080 | 713080 | ANTI-C (ANTI-RH2) (MONOCLONAL) BIOCLONE 1X5ML | BIOCLONE | |||
20 | 10758750003129 | 711520 | 711520 | ANTI-A,B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML | BIOCLONE | |||
21 | 10758750003075 | 711320 | 711320 | ANTI-B (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML | BIOCLONE | |||
22 | 10758750003020 | 711220 | 711220 | ANTI-A (MURINE MONOCLONAL BLEND) BIOCLONE 15X10ML | BIOCLONE | |||
23 | 10758750034581 | 6199976 | 6199976 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators | QKO | Reagent, coronavirus serological | VITROS | |
24 | 10758750034567 | 6199975 | 6199975 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
25 | 10758750033591 | 6199950 | 6199950 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator | QKP | Coronavirus antigen detection test system. | VITROS | |
26 | 10758750033584 | 6199949 | 6199949 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack | QKP | Coronavirus antigen detection test system. | VITROS | |
27 | 10758750033560 | 6199943 | 6199943 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls | QKP | Coronavirus antigen detection test system. | VITROS | |
28 | 10758750033515 | 6802915B | 6802915B | VITROS 5600 Integrated System-Refurbished - Box B | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
29 | 10758750033201 | 6900440 | 6900440 | VITROS 4600 Chemistry System - Refurbished | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
30 | 10758750032136 | 6844288 | 6844288 | VITROS Chemistry Products ALTV Slides | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | VITROS |
31 | 10758750032105 | 6844508 | 6844508 | VITROS Chemistry Products Calibrator Kit 32 | JIX | Calibrator, multi-analyte mixture | 2 | VITROS |
32 | 10758750031986 | 6844458 | 6844458 | VITROS XT 3400 Chemistry System | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
33 | 10758750031801 | 6844296 | 6844296 | VITROS XT Chemistry Products TBIL-ALKP Slides | CJE,CIG | NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES,DIAZO COLORIMETRY, BILIRUBIN | 2 | VITROS |
34 | 10758750031795 | 6844295 | 6844295 | VITROS XT Chemistry Products GLU-Ca Slides | CGA,CJY | GLUCOSE OXIDASE, GLUCOSE,AZO DYE, CALCIUM | 2 | VITROS |
35 | 10758750031788 | 6844294 | 6844294 | VITROS XT Chemistry Products UREA-CREA Slides | CDN,JFY | UREASE, PHOTOMETRIC, UREA NITROGEN,ENZYMATIC METHOD, CREATININE | 2 | VITROS |
36 | 10758750031771 | 6844293 | 6844293 | VITROS XT Chemistry Products ALB-TP Slides | CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN | 2 | VITROS |
37 | 10758750031764 | 6844292 | 6844292 | VITROS XT Chemistry Products TRIG-CHOL Slides | CDT,CHH | LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES,ENZYMATIC ESTERASE--OXID LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES,ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | 1 | VITROS |
38 | 10758750031757 | 6844291 | 6844291 | VITROS XT Chemistry Products ALTV-AST Slides | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | VITROS |
39 | 10758750031610 | 6844461 | 6844461 | VITROS XT 7600 Integrated System | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
40 | 10758750031108 | 6844430 | 6844430 | VITROS Chemistry Products LDHI Slides | CFJ | NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE | 2 | VITROS |
41 | 10758750030736 | 6842906 | 6842906 | VITROS Chemistry Products Calibrator Kit 31 | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
42 | 10758750030729 | 6842905 | 6842905 | VITROS Chemistry Products HbA1c Reagent | PDJ | Hemoglobin A1c test system | 2 | VITROS |
43 | 10758750030163 | 6842957 | 6842957 | VITROS Chemistry Products HCY 2 Performance Verifier I, II, III | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
44 | 10758750030156 | 6842956 | 6842956 | VITROS Chemistry Products HCY 2 Reagent | LPS | URINARY HOMOCYSTINE (NONQUANTITATIVE) TEST SYSTEM | 2 | VITROS |
45 | 10758750012343 | 6802445 | 6802445 | VITROS 4600 Chemistry System | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
46 | 10758750011308 | 6801059B | 6801059B | VITROS ECI IMMUNODIAGNOSTIC SYSTEM - Refurbished - Box B | KHO | FLUOROMETER, FOR CLINICAL USE | 1 | VITROS |
47 | 10758750010233 | 8157596 | 8157596 | VITROS Chemistry Products K+ Slides | CEM | ELECTRODE, ION SPECIFIC, POTASSIUM | 2 | VITROS |
48 | 10758750009862 | 6802413B | 6802413B | VITROS 5600 Integrated System - Box B | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
49 | 10758750009763 | 6801759B | 6801759B | VITROS 250 Chemistry System - Refurbished - Box B | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | VITROS |
50 | 10758750009602 | 1721869 | 1721869 | VITROS Chemistry Products AMON Slides | JID | PHOTOMETRIC METHOD, AMMONIA | 1 | VITROS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10758750033591 | 6199950 | 6199950 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
2 | 10758750033584 | 6199949 | 6199949 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
3 | 10758750033577 | 6199944 | 6199944 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
4 | 10758750033560 | 6199943 | 6199943 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
5 | 10743816001553 | BSP-511-25 | BSP-511-25 | Status™ COVID-19/Flu A&B Antigen test kit, 25 tests | Status™ COVID-19/Flu | PRINCETON BIOMEDITECH CORPORATION |
6 | 08908016644039 | MDSC02 | MDSC02 | COVID-19 Antigen Lateral Flow Test Device. | CoviSelf | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
7 | 08908016644022 | MGPF25 | MGPF25 | COVID-19 Antigen Fluorescence Immunoassay Kit | Gazelle PathoCatch | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
8 | 08908016644015 | MPF25 | MPF25 | COVID-19 Antigen Fluorescence Immunoassay Kit | PathoCatch | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
9 | 08908016644008 | MDSC01 | MDSC01 | COVID-19 Antigen Lateral Flow Test Device. | CoviSelf | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
10 | 08800076700482 | COVAG025-NU | COVAG025-NU | Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior na Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. For use under an emergency use authorization (EUA) only. | GenBody COVID-19 Ag | GENBODY INC. |
11 | 08800076700437 | COVAG025-U | COVAG025-U | Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct n Qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Emergency use of this test is limited to authorized laboratories. | GenBody COVID-19 Ag | GENBODY INC. |
12 | 06942468181683 | BP291-5 | Genabio COVID-19 Rapid Self-Test Kit | Genabio | CORE TECHNOLOGY CO.,LTD. | |
13 | 06942468181676 | BP291-1 | Genabio COVID-19 Rapid Self-Test Kit | Genabio | CORE TECHNOLOGY CO.,LTD. | |
14 | 06921963712950 | 1N40C5-4-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 4 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
15 | 06921963712943 | 1N40C5-10-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 10 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
16 | 06921963712936 | 1N40C5-40-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 40 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
17 | 06921963712929 | 1N40C5-8-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 8 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
18 | 06921963712523 | 1N40C5-20-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 20 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
19 | 06921963712516 | 1N40C5-5-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 5 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
20 | 06921963712509 | 1N40C5-2-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
21 | 06921963712493 | 1N40C5-1-US | Non-prescription home use for the qualitative detection of nucleocapsid protein Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Boson - Rapid SARS-CoV-2 Antigen Test Card - 1 Tests/Kit | XIAMEN BOSON BIOTECH CO., LTD. | |
22 | 00856362005906 | ICO-3000 | iHealth | IHEALTH LAB INC. | ||
23 | 00856362005890 | ICO-3000 | iHealth | IHEALTH LAB INC. | ||
24 | 00855636003716 | 1N40C5-1-US-BS | 1N40C5-1-US-BS | The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chroma The Rapid SARS-CoV-2 Antigen Test Card is a single use rapid lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 and older, when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years and older when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests. The test is authorized for individuals aged 2 years and older with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19. | Rapid SARS-CoV-2 Antigen Test Card | LUMIQUICK DIAGNOSTICS, INC. |
25 | 00850044118069 | ICO-3000 | iHealth | IHEALTH LAB INC. | ||
26 | 00682607660476 | L031-125P5 | 660476 | Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
27 | 00682607660285 | L031-125N5 | 660285 | Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
28 | 00682607660278 | L031-125M5 | 660278 | Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
29 | 00682607660261 | L031-118B5 | 660261 | Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
30 | 00196852953004 | RA9-E00302 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
31 | 00196852928675 | RA9-E00305 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
32 | 00196852254316 | RA9-E00301 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
33 | 00196852195008 | RA9-E00325 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
34 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QuickVue | QUIDEL CORPORATION |
35 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QuickVue | QUIDEL CORPORATION |
36 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QuickVue | QUIDEL CORPORATION |