| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10859035006061 | 60C4 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (5000 TESTS) | |||
| 2 | 10859035006252 | 61C6 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 15 WELL TEST CARDS 300 EA | |||
| 3 | 10859035006160 | 61C9 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ DISPENSING BOTTLES 10 EA | |||
| 4 | 10859035006078 | 60C6 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 30 WELL CARDS KIT (5000 TESTS) | |||
| 5 | 10859035006030 | 60C1 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (50 TESTS) | |||
| 6 | 10859035006214 | 47050 | GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | Wampole ColorCard® ASO | |||
| 7 | 10859035006153 | 61C8 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ NEEDLE/SHEATH 10 EA | |||
| 8 | 10859035006092 | 61C1 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ ANTIGEN SUSPENSION 10 X 3ML | |||
| 9 | 10859035006122 | 61C4 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ PIPETS/STIRRERS 500 EA | |||
| 10 | 10859035006221 | 46050 | GTY | Antigens, All Groups, Streptococcus Spp. | Wampole ColorCard® Streptozyme® | |||
| 11 | 10859035006085 | 61C0 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ ANTIGEN SUSPENSION 3 X 3ML | |||
| 12 | 10859035006016 | 71S2 | DCN | System, Test, C-Reactive Protein | IMMUNEX CRP® | |||
| 13 | 10859035006115 | 61C3 | GMQ | Antigens, Nontreponemal, All | 2 | IMPACT RPR™ LIQUID CONTROL 3 X 1 ML | ||
| 14 | 10859035006245 | 84R2 | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | Alere Rubella-plus® | |||
| 15 | 10859035006184 | 62C5 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 10 WELL TEST CARDS 50 EA | |||
| 16 | 10859035006146 | 61C7 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 30 WELL TEST CARDS 100 EA | |||
| 17 | 10859035006177 | 62C4 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ PIPETS/STIRRERS 250 EA | |||
| 18 | 10859035006207 | 36045 | DHR | System, Test, Rheumatoid Factor | Wampole Colorcard® RF | |||
| 19 | 10859035006191 | 27135 | KTN | System, Test, Infectious Mononucleosis | Wampole ColorCard® Mono | |||
| 20 | 10859035006108 | 61C2 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ DRY CONTROL CARDS 10 EA | |||
| 21 | 10859035006054 | 60C3 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (500 TESTS) | |||
| 22 | 10859035006047 | 60C2 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ TEST KIT (150 TESTS) | |||
| 23 | 10859035006023 | L103E | KHE | Reagent, Occult Blood | DENCOCCULT™ III | |||
| 24 | 10859035006139 | 61C5 | GMQ | Antigens, Nontreponemal, All | IMPACT RPR™ 10 WELL TEST CARDS 300 EA | |||
| 25 | 10859035006009 | 34S2 | DHR | System, Test, Rheumatoid Factor | RHEUMATEX® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00742860100048 | 755725 | 755725 | MONO, MERIDIAN IMMUNO 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 2 | 00742860001451 | 145 | 145 | OSOM Mono 25 Test Kit | SEKISUI DIAGNOSTICS, LLC | |
| 3 | 00722066000311 | MON-13C15 | MON-13C15 | Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualita Rapid Response Mononucleosis Test Cassettes - 15 tests/ kit are for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum or plasma. | Rapid Response | BTNX INC |
| 4 | 00695684770259 | 77025 | A rapid cassette test for the qualitative detection of Infectious Mononucleosis A rapid cassette test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood. | AIMSTEP MONO | GERMAINE LABORATORIES, INC | |
| 5 | 00657498000038 | 6200-020 | 6200-020 | For the Qualitative Detection of Infectious Mononucleosis (IM) Heterophile Antib For the Qualitative Detection of Infectious Mononucleosis (IM) Heterophile Antibodies in Whole blood, Serum or Plasma. | RELY Mono | STANBIO LABORATORY, L.P. |
| 6 | 00613647001325 | T3018-1003 | 23038008 | SURE-VUE MONO 1000 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 7 | 00613647001318 | T3018-1002 | 23038007 | SURE-VUE MONO 150 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 8 | 00613647001301 | T3018-1001 | 23038006 | SURE-VUE MONO 50 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 9 | 00613647001202 | T3018-1005 | 23038017 | Sure-Vue Color Mono 50 T | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 10 | 00613647001196 | T3018-1004 | 23038016 | Sure-Vue Color Mono 24T | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 11 | 00613647000281 | 23-200-275 | 23200275 | Sure-Vue Signature Mononucleosis | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 12 | 00304040001387 | 1125547 | 1125547 | OneStep Pro Plus Mono | Henry Schein OneStep | HENRY SCHEIN, INC. |
| 13 | 00006136471325 | T3018-1003 | 23038008 | SURE-VUE MONO 1000 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 14 | 00006136471318 | T3018-1002 | 23038007 | SURE-VUE MONO 150 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 15 | 00006136471301 | T3018-1001 | 23038006 | SURE-VUE MONO 50 TESTS | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 16 | 00006136471202 | T3018-1005 | 23038017 | Sure-Vue Color Mono 50 T | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 17 | 00006136471196 | T3018-1004 | 23038016 | Sure-Vue Color Mono 24T | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. |
| 18 | 30014613201212 | Mononucleosis Test | 20121 | QuickVue+ Mononucleosis 20T | QuickVue+ | QUIDEL CORPORATION |
| 19 | 20885380183635 | CH28 | CH28 | CH28 - Cardinal Health Mono Cassette | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 20 | 20885380114363 | B1077-9 | B1077-9 | SP Brand Color Mono Latex Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 21 | 20885380057417 | CH1145 | CH1145 | MONO II RAPID TEST | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 22 | 20885380020312 | B1077-28 | B1077-28 | Mono Rapid Test | CARDINAL HEALTH | CARDINAL HEALTH 200, LLC |
| 23 | 20612479202775 | 5012 | TEST KIT, MONO WAIVED APPRV F/ | McKesson | MCKESSON MEDICAL-SURGICAL INC. | |
| 24 | 15099590625900 | 395100 | 395100 | Icon Mono, 30 Test Box | Icon | BECKMAN COULTER, INC. |
| 25 | 10888277191891 | MPH50025M | MPH50025M | TEST,MONO,CASS,25 TEST | Medline | MEDLINE INDUSTRIES, INC. |
| 26 | 10859035006238 | 92407 | Acceava® Mono Cassette | ALERE NORTH AMERICA, LLC | ||
| 27 | 10859035006191 | 27135 | Wampole ColorCard® Mono | ALERE NORTH AMERICA, LLC | ||
| 28 | 10815845020062 | 01P52-25 | Signify® | ALERE SAN DIEGO, INC. | ||
| 29 | 10815845020017 | 92404 | Acceava® | ALERE SAN DIEGO, INC. | ||
| 30 | 10815845020000 | 92401 | Clearview® | ALERE SAN DIEGO, INC. | ||
| 31 | 10763924516299 | ID516 | Rapid Mono Test Device. (Whole Blood/Serum/Plasma) | ACCUTEST Rapid Mono Test | JANT PHARMACAL CORPORATION | |
| 32 | 10743816000983 | BSP-402WB-25-06 | BSP-402WB-25-06 | BioSign Mono card; 25 Test kit (for LifeSign) | BioSign Mono card | PRINCETON BIOMEDITECH CORPORATION |
| 33 | 10743816000976 | BSP-402WB-25-00 | BSP-402WB-25-00 | Status™ Mono card; 25 Test kit (Procedure Card) | Status™ Mono card | PRINCETON BIOMEDITECH CORPORATION |
| 34 | 10743816000969 | BSP-402WB-10-03 | BSP-402WB-10-03 | Status Mono Waived; 10 Test kit (Procedure Card) | Status Mono Waived card | PRINCETON BIOMEDITECH CORPORATION |
| 35 | 10743816000952 | BSP-402WB-30-03 | BSP-402WB-30-03 | Status Mono Waived; 30 Test kit (Procedure Card) | Status Mono Waived card | PRINCETON BIOMEDITECH CORPORATION |
| 36 | 10743816000945 | BSP-402WB-30-02 | BSP-402WB-30-02 | Status Mono Moderate Complex; 30 Test kit | Status Mono Moderate Complex card | PRINCETON BIOMEDITECH CORPORATION |
| 37 | 10743816000938 | BSP-402WB-10-02 | BSP-402WB-10-02 | BioSign® Mono card; 10 Test kit; CE | BioSign® Mono card | PRINCETON BIOMEDITECH CORPORATION |
| 38 | 10743816000921 | BSP-402WB-35-01 | BSP-402WB-35-01 | BioSign® Mono card; 35 Test kit; CE | BioSign® Mono card | PRINCETON BIOMEDITECH CORPORATION |
| 39 | 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 | |
| 40 | 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 | |
| 41 | 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 | |
| 42 | 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 | |
| 43 | 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 | |
| 44 | 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 | |
| 45 | 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 | |
| 46 | 10722355001231 | IMM-100 | A rapid color enhanced slide test for the detection of infectious mononucleosis antibodies | Detector Monocol | IMMUNOSTICS COMPANY, INC | |
| 47 | 10722355001224 | IMM-50 | A rapid color enhanced slide test for the detection of infectious mononucleosis antibodies | Detector Monocol | IMMUNOSTICS COMPANY, INC | |
| 48 | 10722355001217 | IMC-100 | A simple color enhanced slide test for the detection of infectious mononucleosis | Detector Color IM | IMMUNOSTICS COMPANY, INC | |
| 49 | 10722355001200 | IMC-50 | A simple color enhanced slide test for the detection of infectious mononucleosis | Detector Color IM | IMMUNOSTICS COMPANY, INC | |
| 50 | 10304040024130 | 9004070 | 9004070 | One Step + Mono Test | Henry Schein | HENRY SCHEIN, INC. |