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 | 30014613202660 | hCG FIA | 20266 | Sofia hCG 50T | Sofia | QUIDEL CORPORATION |
2 | 30014613202295 | hCG FIA | 20229 | Sofia hCG 50T, US | Sofia | QUIDEL CORPORATION |
3 | 30014613201120 | 20112 | 20112 | RpdVue hCG 25T | QuickVue | QUIDEL CORPORATION |
4 | 30014613201106 | One-Step hCG Combo Test | 20110 | QkVue HCG Combo, 50T | QuickVue | QUIDEL CORPORATION |
5 | 30014613201090 | One-Step hCG Urine Test | 20109 | QkVue hCG Urine 25T | QuickVue | QUIDEL CORPORATION |
6 | 30014613001799 | hCG S/U Test | 00179 | QkVue+ hCG S/U, 90T | QuickVue+ | QUIDEL CORPORATION |
7 | 30014613001782 | hCG S/U Test | 00178 | QkVue+ hCG S/U, 30T | QuickVue+ | QUIDEL CORPORATION |
8 | M90107RD70010 | 07RD7001 | 07RD7001 | immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG) | QuickProfile™ HCG Test Strip | LUMIQUICK DIAGNOSTICS, INC. |
9 | 20888277703572 | MPH12325HCG | MPH12325HCG | TEST,HCG,PREGNANCY,URINE,CASS,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
10 | 20888277703565 | MPH11325HCG | MPH11325HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
11 | 20885380181198 | CH24 | CH24 | Cardinal Health hCG Combo Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
12 | 20885380181181 | CH23 | CH23 | Cardinal Health Premium hCG Combo Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
13 | 20885380181174 | CH22 | CH22 | Cardinal Health Premium hCG Urine Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
14 | 20885380181150 | CH21 | CH21 | Cardinal Health hCG Urine Dipstick | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
15 | 20885380020268 | B1077-23 | B1077-23 | hCG Combo Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
16 | 20885380020251 | B1077-22 | B1077-22 | hCG Cassette Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
17 | 20885380020244 | B1077-21 | B1077-21 | hCG Dipstick Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
18 | 20612479202768 | 5002 | TEST KIT, PREG HCG URINE/SERUM | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
19 | 20612479202751 | 5000 | TEST KIT, PREGNANCY HCG DIPSTI | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
20 | 20612479202744 | 5001 | TEST KIT, PREG HCG CASSETTE WA | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
21 | 20607415000119 | 82789 | hCG Dipstick MMC | Moore Medical | MOORE MEDICAL LLC | |
22 | 20607415000096 | 82791 | HCG Serum/Urine MMC | Moore Medical | MOORE MEDICAL LLC | |
23 | 20607415000072 | 82790 | hCG Cassette MMC | Moore Medical | MOORE MEDICAL LLC | |
24 | 15099590776886 | 43025 | 43025 | Icon 25 HCG, Box of 25 Tests | ICON 25 hCG | BECKMAN COULTER, INC. |
25 | 15099590625948 | 395097 | 395097 | Icon 20 HCG, Box of 25 Tests | Icon | BECKMAN COULTER, INC. |
26 | 14560189210841 | N/A | ST AIA-PACK HCG | TOSOH CORPORATION | ||
27 | 14560189210063 | N/A | ST AIA-PACK βHCG | TOSOH CORPORATION | ||
28 | 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. |
29 | 10888277191877 | MPH12025HCG | MPH12025HCG | TEST,HCG,PREGNANCY,URINE,CASS, 25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
30 | 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. | |
31 | 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. | |
32 | 10884389191880 | MPH22025HCG | MPH22025HCG | TEST,HCG,PREGNANCY,COMBO,CASS,20/10 MIU | Medline | MEDLINE INDUSTRIES, INC. |
33 | 10884389191873 | MPH11025HCG | MPH11025HCG | TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU | Medline | MEDLINE INDUSTRIES, INC. |
34 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | FastPack® IP hCG Kit (30) | QUALIGEN INC. |
35 | 10815845020130 | 92210 | AlereTM | ALERE SAN DIEGO, INC. | ||
36 | 10815845020123 | 92215 | AlereTM | ALERE SAN DIEGO, INC. | ||
37 | 10815845020116 | 92225 | AlereTM | ALERE SAN DIEGO, INC. | ||
38 | 10815845020109 | 92217 | AlereTM | ALERE SAN DIEGO, INC. | ||
39 | 10815845020093 | 92211 | AlereTM | ALERE SAN DIEGO, INC. | ||
40 | 10796918000108 | 02-2493 | HCG Combo Cassette Test | Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
41 | 10796918000092 | 02-2489 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
42 | 10796918000085 | 02-2488 | INSTANT-VIEW HCG Combo Dip-Strip Test | INSTANT-VIEW Pregnancy Combo Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
43 | 10796918000078 | 02-2487-25 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
44 | 10796918000061 | 02-2487 | INSTANT-VIEW HCG Urine Dip-Strip Test | INSTANT-VIEW Pregnancy Urine Dip-Strip Test | ALFA SCIENTIFIC DESIGNS, INC. | |
45 | 10796918000054 | 02-2486 | Instant-View HCG Urine Cassette,4mm | INSTANT-VIEW Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
46 | 10796918000047 | 02-2484 | Instant-View HCG Combo Cassette, 4mm | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
47 | 10796918000030 | 02-2483 | INSTANT-VIEW HCG Combo Cassette Test | INSTANT-VIEW Pregnancy Combo Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
48 | 10796918000023 | 02-2482 | INSTANT-VIEW HCG Urine Cassette Test | Insant-View Pregnancy Urine Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
49 | 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 | |
50 | 10763924853202 | PF853 | Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived) | Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived) | JANT PHARMACAL CORPORATION |