No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30014613336754 | RPS-ID-20-U | RPS-ID-20-U | InflammaDry | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | InflammaDry |
2 | 30014613336747 | RPS-ID-20 | RPS-ID-20 | InflammaDry | PFQ,JJX | MMP-9 test system,Single (specified) analyte controls (assayed and unassayed) | 1 | InflammaDry |
3 | 30014613336402 | Trichomonas Assay | M304.U | SolanaTrichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
4 | 30014613336396 | Trichomonas Assay | M304.S | Solana Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | Solana |
5 | 30014613336082 | Group A Strep Assay | M301 | Solana GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Solana |
6 | 30014613335580 | C1-Inhibitor | A037 | MicroVue C1-Inhibitor Plus EIA | DBA | COMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
7 | 30014613335573 | Bp Plus EIA | A027 | Kit, Quidel Bb Plus | JZH | FACTOR B, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
8 | 30014613335566 | CH50 Eq EIA | A018 | MicroVue CH50 Eq EIA | DAE | COMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
9 | 30014613335559 | CIC-C1q Controls | A013 | MicroVue CIC-C1q Ctrls | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
10 | 30014613335542 | CIC-Raji EIA | A002 | MicroVue CIC-Raji EIA | CZY | COMPLEMENT C1S, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
11 | 30014613335535 | CIC-C1q EIA | A001 | MicroVue CIC-C1q EIA | DAK | COMPLEMENT C1Q, ANTIGEN, ANTISERUM, CONTROL | 2 | MicroVue |
12 | 30014613333951 | Vitamin D EIA | 8046 | MicroVue Vitamin D EIA | MRG | SYSTEM, TEST, VITAMIN D | 2 | MicroVue |
13 | 30014613333944 | PTH EIA | 8044 | MicroVue PTH EIA | CEW | RADIOIMMUNOASSAY, PARATHYROID HORMONE | 2 | MicroVue |
14 | 30014613333937 | Calcitonin EIA | 8043 | MicroVue Calcitonin EIA | JKR | RADIOIMMUNOASSAY, CALCITONIN | 2 | MicroVue |
15 | 30014613333920 | BAP EIA | 8012 | MicroVue BAP EIA | CIN | ELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES | 2 | MicroVue |
16 | 30014613333913 | PYD EIA | 8010 | Kit, McVu PYD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
17 | 30014613333906 | DPD EIA | 8007 | Kit, McVu DPD | JMM | COLUMN CHROMATOGRAPHY & COLOR DEVELOPMENT, HYDROXYPROLINE | 1 | MicroVue |
18 | 30014613311140 | Parainfluenza Virus Assay | M114 | Lyra Parainfluenza Assay | OOU | Parainfluenza multiplex nucleic acid assay | 2 | Lyra |
19 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | OCC | Respiratory virus panel nucleic acid assay system | 2 | Lyra |
20 | 30014613311126 | Direct Strep Assay | M112 | Lyra Direct Strep Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | Lyra |
21 | 30014613311058 | Direct C. difficile Assay | M105 | Lyra Direct CDIFF Assay | OZN,OOI | C.Difficile toxin gene amplification assay,real time Nucleic acid amplification system | 2 | Lyra |
22 | 30014613311027 | Direct HSV 1+2/VZV Assay | M102 | Lyra Direct HSV 1+2/VZV Assay | PGI | Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutane Herpes virus (VZV, HSV1, HSV2), DNA Detection Assay for cutaneous and mucocutaneous lesion samples | 2 | Lyra |
23 | 30014613202783 | 20278 | 20278 | Solana instrument | NSU | Instrumentation for clinical multiplex test systems | 2 | Solana |
24 | 30014613003458 | 00345 | 00345 | QkVue InLine Strep A Ctrl Set | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
25 | 30014613003434 | 00343 | 00343 | QkVue InLine Strep A 25T | GTZ | ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue In-Line |
26 | 30014613336686 | RPS-AD | RPS-AD | AdenoPlus | GOD | ANTIGENS, CF (INCLUDING CF CONTROL), ADENOVIRUS 1-33 | 1 | AdenoPlus |
27 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
28 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
29 | 30014613339373 | 20387 | 20387 | QuickVue® SARS Antigen Test | QuickVue | |||
30 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
31 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
32 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | LYR | Helicobacter pylori | 1 | QuickVue |
33 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | LYR | Helicobacter pylori | 1 | QuickVue |
34 | 30014613312123 | Group A Strep Assay | M212 | AmpliVue GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | AmpliVue |
35 | 30014613312116 | Trichomonas Assay | M211 | AmpliVue Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | AmpliVue |
36 | 30014613312109 | HSV 1+2 Assay | M210 | AmpliVue HSV 1+2 Assay | OQO | Herpes simplex virus nucleic acid amplification assay | 2 | AmpliVue |
37 | 30014613312093 | Bordetella Assay | M209 | AmpliVue Bordetella Assay | OZZ | Bordetella pertussis dna assay system | 2 | AmpliVue |
38 | 30014613312024 | GBS Assay | M202 | AmpliVue GBS Assay | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | AmpliVue |
39 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | OZN | C.Difficile toxin gene amplification assay | 2 | AmpliVue |
40 | 30014613202226 | 20222 | 20222 | QkVue RSV 10, 25T | GQG | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
41 | 30014613202059 | iFOB Test | 20205 | QuickVue iFOB Test Dev Kit 100T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
42 | 30014613202042 | iFOB Test | 20204 | QuickVue iFOB Collect Kit 40T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
43 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
44 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
47 | 30014613201939 | 20193 | 20193 | QkVue RSV 20T | MCE,GQG | RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRA RESPIRATORY SYNCYTIAL VIRUS - ELISA,ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
48 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
49 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
50 | 30014613201250 | 20125 | 20125 | QkVue Strep A Dpstk 25T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00682607660476 | L031-125P5 | 660476 | Test Cassettes (25), Extraction Buffer Tubes (25), Nasal Swabs (25) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
2 | 00682607660285 | L031-125N5 | 660285 | Test Cassettes (5), Extraction Buffer Tubes (5), Nasal Swabs (5) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
3 | 00682607660278 | L031-125M5 | 660278 | Test Cassettes (2), Extraction Buffer Tubes (2), Nasal Swabs (2) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
4 | 00682607660261 | L031-118B5 | 660261 | Test Cassette (1), Extraction Buffer Tube (1), Nasal Swab (1) | Flowflex COVID-19 Antigen Home Test | ACON LABORATORIES, INC. |
5 | 00196852953004 | RA9-E00302 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
6 | 00196852928675 | RA9-E00305 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
7 | 00196852254316 | RA9-E00301 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
8 | 00196852195008 | RA9-E00325 | Genabio COVID-19 Rapid Self-Test Kit | GENABIO DIAGNOSTICS INC. | ||
9 | 30014613339724 | 20402 | 20402 | QuickVue At-Home OTC COVID-19 Test | QuickVue | QUIDEL CORPORATION |
10 | 30014613339687 | 20399 | 20399 | QuickVue At-Home OTC COVID-19 Test | QuickVue | QUIDEL CORPORATION |
11 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QuickVue | QUIDEL CORPORATION |
12 | 10758750033591 | 6199950 | 6199950 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
13 | 10758750033584 | 6199949 | 6199949 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
14 | 10758750033577 | 6199944 | 6199944 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Extraction Buffer | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
15 | 10758750033560 | 6199943 | 6199943 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Controls | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
16 | 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 |
17 | 08908016644039 | MDSC02 | MDSC02 | COVID-19 Antigen Lateral Flow Test Device. | CoviSelf | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
18 | 08908016644022 | MGPF25 | MGPF25 | COVID-19 Antigen Fluorescence Immunoassay Kit | Gazelle PathoCatch | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
19 | 08908016644015 | MPF25 | MPF25 | COVID-19 Antigen Fluorescence Immunoassay Kit | PathoCatch | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
20 | 08908016644008 | MDSC01 | MDSC01 | COVID-19 Antigen Lateral Flow Test Device. | CoviSelf | MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED |
21 | 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. |
22 | 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. |
23 | 06942468181683 | BP291-5 | Genabio COVID-19 Rapid Self-Test Kit | Genabio | CORE TECHNOLOGY CO.,LTD. | |
24 | 06942468181676 | BP291-1 | Genabio COVID-19 Rapid Self-Test Kit | Genabio | CORE TECHNOLOGY CO.,LTD. | |
25 | 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. | |
26 | 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. | |
27 | 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. | |
28 | 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. | |
29 | 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. | |
30 | 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. | |
31 | 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. | |
32 | 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. | |
33 | 00856362005906 | ICO-3000 | iHealth | IHEALTH LAB INC. | ||
34 | 00856362005890 | ICO-3000 | iHealth | IHEALTH LAB INC. | ||
35 | 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. |
36 | 00850044118069 | ICO-3000 | iHealth | IHEALTH LAB INC. |