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 | 10888277191891 | MPH50025M | MPH50025M | TEST,MONO,CASS,25 TEST | Medline | MEDLINE INDUSTRIES, INC. |
2 | 10859035006238 | 92407 | Acceava® Mono Cassette | ALERE NORTH AMERICA, LLC | ||
3 | 10859035006191 | 27135 | Wampole ColorCard® Mono | ALERE NORTH AMERICA, LLC | ||
4 | 10815845020062 | 01P52-25 | Signify® | ALERE SAN DIEGO, INC. | ||
5 | 10815845020017 | 92404 | Acceava® | ALERE SAN DIEGO, INC. | ||
6 | 10815845020000 | 92401 | Clearview® | ALERE SAN DIEGO, INC. | ||
7 | 10763924516299 | ID516 | Rapid Mono Test Device. (Whole Blood/Serum/Plasma) | ACCUTEST Rapid Mono Test | JANT PHARMACAL CORPORATION | |
8 | 10743816000983 | BSP-402WB-25-06 | BSP-402WB-25-06 | BioSign Mono card; 25 Test kit (for LifeSign) | BioSign Mono card | PRINCETON BIOMEDITECH CORPORATION |
9 | 10743816000976 | BSP-402WB-25-00 | BSP-402WB-25-00 | Status™ Mono card; 25 Test kit (Procedure Card) | Status™ Mono card | PRINCETON BIOMEDITECH CORPORATION |
10 | 10743816000969 | BSP-402WB-10-03 | BSP-402WB-10-03 | Status Mono Waived; 10 Test kit (Procedure Card) | Status Mono Waived card | PRINCETON BIOMEDITECH CORPORATION |
11 | 10743816000952 | BSP-402WB-30-03 | BSP-402WB-30-03 | Status Mono Waived; 30 Test kit (Procedure Card) | Status Mono Waived card | PRINCETON BIOMEDITECH CORPORATION |
12 | 10743816000945 | BSP-402WB-30-02 | BSP-402WB-30-02 | Status Mono Moderate Complex; 30 Test kit | Status Mono Moderate Complex card | PRINCETON BIOMEDITECH CORPORATION |
13 | 10743816000938 | BSP-402WB-10-02 | BSP-402WB-10-02 | BioSign® Mono card; 10 Test kit; CE | BioSign® Mono card | PRINCETON BIOMEDITECH CORPORATION |
14 | 10743816000921 | BSP-402WB-35-01 | BSP-402WB-35-01 | BioSign® Mono card; 35 Test kit; CE | BioSign® Mono card | PRINCETON BIOMEDITECH CORPORATION |
15 | 10722355001651 | MCLX-25 | A rapid color enhanced latex agglutination slide test for the detection of heter A rapid color enhanced latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis | Detector Monocol Lex | IMMUNOSTICS COMPANY, INC | |
16 | 10722355001491 | IMLX-25 | A rapid latex agglutination slide test for the detection of heterophile antibodi A rapid latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis | Detector Lex-IM | IMMUNOSTICS COMPANY, INC | |
17 | 10722355001286 | MCLX-100 | A rapid color enhanced latex agglutination slide test for the detection of heter A rapid color enhanced latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis | Detector Monocol Lex | IMMUNOSTICS COMPANY, INC | |
18 | 10722355001279 | MCLX-50 | A rapid color enhanced latex agglutination slide test for the detection of heter A rapid color enhanced latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis | Detector Monocol Lex | IMMUNOSTICS COMPANY, INC | |
19 | 10722355001262 | IMLX-100 | A rapid latex agglutination slide test for the detection of heterophile antibodi A rapid latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis | Detector Lex-IM | IMMUNOSTICS COMPANY, INC | |
20 | 10722355001255 | IDM-25 | A qualitative immunoassay for the detection of infectious mononucleosis heteroph A qualitative immunoassay for the detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma | Detector Mono | IMMUNOSTICS COMPANY, INC | |
21 | 10722355001248 | IMLX-50 | A rapid latex agglutination slide test for the detection of heterophile antibodi A rapid latex agglutination slide test for the detection of heterophile antibodies associated with infectious mononucleosis | Detector Lex-IM | IMMUNOSTICS COMPANY, INC | |
22 | 10722355001231 | IMM-100 | A rapid color enhanced slide test for the detection of infectious mononucleosis antibodies | Detector Monocol | IMMUNOSTICS COMPANY, INC | |
23 | 10722355001224 | IMM-50 | A rapid color enhanced slide test for the detection of infectious mononucleosis antibodies | Detector Monocol | IMMUNOSTICS COMPANY, INC | |
24 | 10722355001217 | IMC-100 | A simple color enhanced slide test for the detection of infectious mononucleosis | Detector Color IM | IMMUNOSTICS COMPANY, INC | |
25 | 10722355001200 | IMC-50 | A simple color enhanced slide test for the detection of infectious mononucleosis | Detector Color IM | IMMUNOSTICS COMPANY, INC | |
26 | 10304040024130 | 9004070 | 9004070 | One Step + Mono Test | Henry Schein | HENRY SCHEIN, INC. |
27 | M220P0800163 | P080016 | P080016 | Pro Advantage Infectious Mono 20TST/KT | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
28 | 08426950585350 | 3000-1002 | 3 x 1.4 ml REAGENT1 x 2.0 ml CONTROL +1 x 2.0 ml CONTROL –3 x 9 SLIDES | Monogen 150 TESTS | BIOKIT, S.A. | |
29 | 08426950344773 | 3000-1005 | 1.4 ml REAGENT1.0 ml CONTROL + 1.0 ml CONTROL –2 x 9 SLIDES | Color Mono 50 TESTS | BIOKIT, S.A. | |
30 | 08426950001676 | 3000-1001 | 1.4 ml REAGENT1.0 ml CONTROL +1.0 ml CONTROL –9 SLIDES | Monogen 50 TESTS | BIOKIT, S.A. | |
31 | 00848838076817 | DR0780M | NA | REMEL, INC. | ||
32 | 00848838065385 | R2471088 | NA | REMEL, INC. | ||
33 | 00848838065279 | R2468944 | NA | REMEL, INC. | ||
34 | 00848838065262 | R2468936 | NA | REMEL, INC. | ||
35 | 00848838031601 | R421022 | NA | REMEL, INC. | ||
36 | 00848838031588 | R421021 | NA | REMEL, INC. | ||
37 | 00847865011358 | SW4V2 | 6651360F | Manual & CDs, EBV IgM IFU, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
38 | 00847865011341 | 6651360G | 6651360G | Manual & CDs, EBV IgM IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
39 | 00847865002455 | 6651370C | 6651370C | EBV IgM Assay Protocol File CD, SW4_v2 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
40 | 00847865001236 | SW4.1_V1 | 6651370D | EBV IgM Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
41 | 00847865000291 | 6651350 | 6651350 | EBV IgG Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
42 | 00840733101298 | 776150 | 776150 | MONOSPOT Latex is a one step rapid latex particle agglutination test for the qua MONOSPOT Latex is a one step rapid latex particle agglutination test for the qualitative and semiquantitative determination of infectious mononucleosis heterophile antibodies in serum or plasma. | MONOSPOT Latex | MERIDIAN BIOSCIENCE, INC. |
43 | 00816917021546 | MN20 | Mono, Immunochromatographic | Poly stat | POLYMEDCO, INC. | |
44 | 00816057021611 | NC-455001 | NC-455001 | Detection of heterophil antibodies associated with infectious mononucleosis | ASI Color Mono II Control Set | ARLINGTON SCIENTIFIC, INC. |
45 | 00816057020324 | NC-4501000 | NC-4501000 | Detection of heterophil antibodies associated with infectious mononucleosis | ASI Color Mono II Test | ARLINGTON SCIENTIFIC, INC. |
46 | 00816057020317 | NC-450100E | NC-450100E | Detection of heterophil antibodies associated with infectious mononucleosis, Export | ASI Color Mono II Test | ARLINGTON SCIENTIFIC, INC. |
47 | 00816057020300 | NC-450100 | NC-450100 | Detection of heterophil antibodies associated with infectious mononucleosis | ASI Color Mono II Test | ARLINGTON SCIENTIFIC, INC. |
48 | 00816057020294 | NC-450050E | NC-450050E | Detection of heterophil antibodies associated with infectious mononucleosis, Export | ASI Color Mono II Test | ARLINGTON SCIENTIFIC, INC. |
49 | 00816057020287 | NC-450050 | NC-450050 | Detection of heterophil antibodies associated with infectious mononucleosis | ASI Color Mono II Test | ARLINGTON SCIENTIFIC, INC. |
50 | 00816057020270 | NC-450025E | NC-450025E | Detection of heterophil antibodies associated with infectious mononucleosis, Export | ASI Color Mono II Test | ARLINGTON SCIENTIFIC, INC. |