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 | 30014613339670 | 20398 | 20398 | QuickVue At-Home OTC COVID-19 Test | QKP | Coronavirus antigen detection test system. | QuickVue | |
30 | 30014613339373 | 20387 | 20387 | QuickVue® SARS Antigen Test | QuickVue | |||
31 | 30014613331469 | 20189 | 20189 | QkVue Flu A+B 20K-T, Bulk | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
32 | 30014613331452 | 20163 | 20163 | QkVue Strep A Dpstk, 4T Samp | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
33 | 30014613320104 | 0W010 | 0W010 | QkVue H pylori gII 30T | LYR | Helicobacter pylori | 1 | QuickVue |
34 | 30014613320098 | 0W009 | 0W009 | QkVue H pylori gII 10T | LYR | Helicobacter pylori | 1 | QuickVue |
35 | 30014613312123 | Group A Strep Assay | M212 | AmpliVue GAS Assay | PGX | Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system | 2 | AmpliVue |
36 | 30014613312116 | Trichomonas Assay | M211 | AmpliVue Trichomonas Assay | OUY | Trichomonas vaginalis nucleic acid amplification test system | 2 | AmpliVue |
37 | 30014613312109 | HSV 1+2 Assay | M210 | AmpliVue HSV 1+2 Assay | OQO | Herpes simplex virus nucleic acid amplification assay | 2 | AmpliVue |
38 | 30014613312093 | Bordetella Assay | M209 | AmpliVue Bordetella Assay | OZZ | Bordetella pertussis dna assay system | 2 | AmpliVue |
39 | 30014613312024 | GBS Assay | M202 | AmpliVue GBS Assay | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | AmpliVue |
40 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | OZN | C.Difficile toxin gene amplification assay | 2 | AmpliVue |
41 | 30014613202226 | 20222 | 20222 | QkVue RSV 10, 25T | GQG | ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS | 1 | QuickVue |
42 | 30014613202059 | iFOB Test | 20205 | QuickVue iFOB Test Dev Kit 100T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
43 | 30014613202042 | iFOB Test | 20204 | QuickVue iFOB Collect Kit 40T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
44 | 30014613202011 | iFOB Test | 20201 | QuickVue iFOB Tray Pack 50T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
45 | 30014613201977 | 20197 | 20197 | QkVue iFOB Control Set | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
46 | 30014613201960 | iFOB Test | 20196 | QuickVue iFOB Collect Kit 10T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
47 | 30014613201946 | iFOB Test | 20194 | QuickVue iFOB 20T | KHE | REAGENT, OCCULT BLOOD | 2 | QuickVue |
48 | 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 |
49 | 30014613201830 | 20183 | 20183 | QkVue Flu A+B 25T, CE | GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C | 1 | QuickVue |
50 | 30014613201526 | 20152 | 20152 | QkVue Strep A Dpstk 10T | GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | 1 | QuickVue |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B24225HCGHUE010 | 25-HCGHU-E01 | 25-HCGHU-E01 | The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative d The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. | Human Chorionic Gonadotropin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
2 | 30014613202660 | hCG FIA | 20266 | Sofia hCG 50T | Sofia | QUIDEL CORPORATION |
3 | 30014613202295 | hCG FIA | 20229 | Sofia hCG 50T, US | Sofia | QUIDEL CORPORATION |
4 | 30014613201120 | 20112 | 20112 | RpdVue hCG 25T | QuickVue | QUIDEL CORPORATION |
5 | 30014613201106 | One-Step hCG Combo Test | 20110 | QkVue HCG Combo, 50T | QuickVue | QUIDEL CORPORATION |
6 | 30014613201090 | One-Step hCG Urine Test | 20109 | QkVue hCG Urine 25T | QuickVue | QUIDEL CORPORATION |
7 | 30014613001799 | hCG S/U Test | 00179 | QkVue+ hCG S/U, 90T | QuickVue+ | QUIDEL CORPORATION |
8 | 30014613001782 | hCG S/U Test | 00178 | QkVue+ hCG S/U, 30T | QuickVue+ | QUIDEL CORPORATION |
9 | M90107RD70010 | 07RD7001 | 07RD7001 | immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG) | QuickProfile™ HCG Test Strip | LUMIQUICK DIAGNOSTICS, INC. |
10 | 20888277703572 | MPH12325HCG | MPH12325HCG | TEST,HCG,PREGNANCY,URINE,CASS,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
11 | 20888277703565 | MPH11325HCG | MPH11325HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
12 | 20885380181198 | CH24 | CH24 | Cardinal Health hCG Combo Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
13 | 20885380181181 | CH23 | CH23 | Cardinal Health Premium hCG Combo Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
14 | 20885380181174 | CH22 | CH22 | Cardinal Health Premium hCG Urine Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
15 | 20885380181150 | CH21 | CH21 | Cardinal Health hCG Urine Dipstick | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
16 | 20885380020268 | B1077-23 | B1077-23 | hCG Combo Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
17 | 20885380020251 | B1077-22 | B1077-22 | hCG Cassette Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
18 | 20885380020244 | B1077-21 | B1077-21 | hCG Dipstick Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
19 | 20612479202768 | 5002 | TEST KIT, PREG HCG URINE/SERUM | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
20 | 20612479202751 | 5000 | TEST KIT, PREGNANCY HCG DIPSTI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
21 | 20612479202744 | 5001 | TEST KIT, PREG HCG CASSETTE WA | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
22 | 20607415000119 | 82789 | hCG Dipstick MMC | Moore Medical | MOORE MEDICAL LLC | |
23 | 20607415000096 | 82791 | HCG Serum/Urine MMC | Moore Medical | MOORE MEDICAL LLC | |
24 | 20607415000072 | 82790 | hCG Cassette MMC | Moore Medical | MOORE MEDICAL LLC | |
25 | 15099590776886 | 43025 | 43025 | Icon 25 HCG, Box of 25 Tests | ICON 25 hCG | BECKMAN COULTER, INC. |
26 | 15099590625948 | 395097 | 395097 | Icon 20 HCG, Box of 25 Tests | Icon | BECKMAN COULTER, INC. |
27 | 14560189210841 | N/A | ST AIA-PACK HCG | TOSOH CORPORATION | ||
28 | 14560189210063 | N/A | ST AIA-PACK βHCG | TOSOH CORPORATION | ||
29 | 10894175000081 | DACD 113029-1-19 | 113029-1-19 | OneStep hCG Combo Urine/Serum RapiCard™ InstaTestA collection of reagents and ot OneStep hCG Combo Urine/Serum RapiCard™ InstaTestA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of total human chorionic gonadotropin (HCG), which may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. | OneStep | DIAGNOSTIC AUTOMATION, INC. |
30 | 10888277191877 | MPH12025HCG | MPH12025HCG | TEST,HCG,PREGNANCY,URINE,CASS, 25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
31 | 10885632116308 | MC02SU | Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made Wit Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
32 | 10885632116285 | MC001U | Kit Human Chorionic Gonadotropin Pregnancy Test Urine 25-Test Not Made With Natu Kit Human Chorionic Gonadotropin Pregnancy Test Urine 25-Test Not Made With Natural Rubber Latex MediChoice | Medichoice | OWENS & MINOR DISTRIBUTION, INC. | |
33 | 10884389191880 | MPH22025HCG | MPH22025HCG | TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU | Medline | MEDLINE INDUSTRIES, INC. |
34 | 10884389191873 | MPH11025HCG | MPH11025HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
35 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | FastPack® IP hCG Kit (30) | QUALIGEN INC. |
36 | 10815845020130 | 92210 | AlereTM | ALERE SAN DIEGO, INC. | ||
37 | 10815845020123 | 92215 | AlereTM | ALERE SAN DIEGO, INC. | ||
38 | 10815845020116 | 92225 | AlereTM | ALERE SAN DIEGO, INC. | ||
39 | 10815845020109 | 92217 | AlereTM | ALERE SAN DIEGO, INC. | ||
40 | 10815845020093 | 92211 | AlereTM | ALERE SAN DIEGO, INC. | ||
41 | 10796918000108 | 02-2493 | HCG Combo Cassette Test | Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
42 | 10796918000092 | 02-2489 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
43 | 10796918000085 | 02-2488 | INSTANT-VIEW HCG Combo Dip-Strip Test | INSTANT-VIEW Pregnancy Combo Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
44 | 10796918000078 | 02-2487-25 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
45 | 10796918000061 | 02-2487 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
46 | 10796918000054 | 02-2486 | Instant-View HCG Urine Cassette,4mm | INSTANT-VIEW Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
47 | 10796918000047 | 02-2484 | Instant-View HCG Combo Cassette, 4mm | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
48 | 10796918000030 | 02-2483 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
49 | 10796918000023 | 02-2482 | INSTANT-VIEW HCG Urine Cassette Test | Insant-View Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
50 | 10763924864208 | PF864 | Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) | Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) | JANT PHARMACAL CORPORATION |