No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30816101025092 | MOL1455 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc Kit | ||
2 | 20816101025651 | MOL3560 | MOL3560 | OOI,NJR | Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay Sys Real Time Nucleic Acid Amplification System,Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | 1 | Simplexa™ GBS Positive Control Pack | |
3 | 10816101022387 | EL0928 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect ELISA Sample Diluent | ||
4 | 10816101022110 | EL0907 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Cutoff Calibrator | ||
5 | 10816101022103 | EL0906 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Low Positive Control | ||
6 | 10816101022066 | EL0322 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Antigen | ||
7 | 10816101022059 | EL0315 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Positive Control | ||
8 | 30816101025085 | MOL1451 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc | ||
9 | 10816101022165 | EL0916 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Conjugate | ||
10 | 20816101026962 | MOL2655 | Simplexa™ Flu A/B & RSV Direct Gen II | |||||
11 | 20816101025606 | MOL2960 | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Simplexa™ C. difficile Positive Control Pack | ||
12 | 20816101025552 | MOL2660 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV Positive Control Pack | ||
13 | 20816101025507 | MOL2150 | MOL2150 | PGH | Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel | 2 | Simplexa™ HSV 1 & 2 Direct | |
14 | 20816101025101 | SC1100 | Simplexa™ Spectral Calibration Panel | |||||
15 | 10816101022356 | EL0405 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - 10X Wash Buffer | ||
16 | 10816101022332 | EL0311 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control | ||
17 | 10816101022301 | EL0105 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - Stop Reagent | ||
18 | 10816101022271 | EL0302 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ Anti-Flavivirus Conjugate | ||
19 | 10816101022240 | EL1708 | MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | 2 | DxSelect™ Amber Sample Diluent | ||
20 | 10816101022226 | EL1608 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ Sample Diluent | ||
21 | 10816101022097 | EL0905 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG High Positive Control | ||
22 | 10816101020055 | IF0951 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Substrate Slides | ||
23 | 20816101025583 | MOL2975 | OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | Simplexa™ C. difficile Universal Direct | ||
24 | 20816101025576 | MOL2860 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Simplexa™ Group A Strep Positive Control Pack | ||
25 | 20816101025538 | MOL2600 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV | ||
26 | 20816101022155 | EL0910G-5 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
27 | 20816101022148 | EL0910G | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
28 | 10816101025036 | MOL1011-P | OOI | Real Time Nucleic Acid Amplification System | 2 | Integrated Cycler (220V) Pre-Owned | ||
29 | 10816101022349 | EL0351 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Antigen Wells | ||
30 | 10816101022318 | EL0304 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Conjugate | ||
31 | 10816101022295 | EL0009 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - Substrate Reagent | ||
32 | 10816101022080 | EL0904 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV ELISA Negative Control | ||
33 | 20816101025569 | MOL2850 | PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 2 | Simplexa™ Group A Strep Direct | ||
34 | 20816101025521 | MOL2500 | OQW | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification | 2 | Simplexa™ Influenza A H1N1 (2009) | ||
35 | 10816101022134 | EL0909 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Low Positive Control | ||
36 | 10816101022127 | EL0908 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG High Positive Control | ||
37 | 10816101020024 | IF0913 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Non-Detectable Control | ||
38 | 10816101020017 | IF0010 | LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | Legionella IFA Polyvalent Conjugate | ||
39 | 30816101025078 | MOL1401 | OOI | Real Time Nucleic Acid Amplification System | 2 | Universal Disc | ||
40 | 40816101025082 | MOL1451 | OOI | Real Time Nucleic Acid Amplification System | 2 | Direct Amplification Disc | ||
41 | 40816101025075 | MOL1400 | OOI | Real Time Nucleic Acid Amplification System | 2 | Universal Disc | ||
42 | 20816101025774 | MOL3650 | PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | 2 | Simplexa™ VZV Direct | ||
43 | 20816101025545 | MOL2650 | OCC | Respiratory Virus Panel Nucleic Acid Assay System | 2 | Simplexa™ Flu A/B & RSV Direct | ||
44 | 10816101025005 | MOL1001 | OOI | Real Time Nucleic Acid Amplification System | 2 | Integrated Cyler (110V) | ||
45 | 10816101022363 | EL0901 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 IgG Antigen Wells | ||
46 | 10816101022288 | EL0303 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgM Capture DxSelect™ IgM Cutoff Calibrator (0.3 mL) | ||
47 | 10816101022172 | EL0917 | MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | HSV-2 ELISA IgG Conjugate | ||
48 | 10816101022073 | EL0903 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV-1 ELISA IgG Cutoff Calibrator | ||
49 | 10816101021038 | IB0910 | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | HSV-1 and HSV-2 Immunoblot IgG Negative Control | ||
50 | 10816101021014 | IB0901 | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00857573006362 | 30-002-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Stool Sample Preparation Kit | NANOSPHERE, INC. | |
2 | 00857573006317 | 20-011-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Amplification Tray | NANOSPHERE, INC. | |
3 | 00857573006256 | 20-009-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative m The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Extraction Tray | NANOSPHERE, INC. | |
4 | 00857573006157 | 20-006-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative mul The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Nucleic Acid Test Cartridge | NANOSPHERE, INC. | |
5 | 00840733102349 | 410300 | 401300 | The Revogene C. difficile assay performed on the Revogene instrument is a qualit The Revogene C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection. The Revogene C. difficile assay is intended to aid in the diagnosis of CDI. | Revogene C. difficile | MERIDIAN BIOSCIENCE, INC. |
6 | 00840487101735 | 30-002-022 | 30-002-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative mul The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Stool Sample Preparation Kit | LUMINEX CORPORATION |
7 | 00840487101704 | 20-011-022 | 20-011-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative mul The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Amplification Tray | LUMINEX CORPORATION |
8 | 00840487101650 | 20-009-022 | 20-009-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative mul The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Extraction Tray | LUMINEX CORPORATION |
9 | 00840487101605 | 20-006-022 | 20-006-022 | The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative mul The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). | Clostridium difficile (CDF) Nucleic Acid Test Cartridge | LUMINEX CORPORATION |
10 | 00840487100059 | 50-10018 | The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) bas The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI). | ARIES® C. difficile Assay | LUMINEX CORPORATION | |
11 | 00628055344124 | 410300 | 410300 | The Revogene® C. difficile assay performed on the Revogene instrument is a quali The Revogene® C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The Revogene C. difficile assay is intended to aid in the diagnosis of CDI. | Revogene® C. difficile | MERIDIAN BIOSCIENCE CANADA INC |
12 | 00628055344025 | 132994 | 132994 | The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative The GenePOC™ CDiff assay performed on the revogene™ instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The GenePOC CDiff assay is intended to aid in the diagnosis of CDI. | GenePOC™ CDiff | GENEPOC INC |
13 | 00382904434182 | 443418 | 443418 | Kit BD MAX Cdiff USA | BD MAX™ Cdiff (US) | BECTON, DICKINSON AND COMPANY |
14 | B178GBCDIFF100 | GBCDIFF-10 | GBCDIFF-10 | C. diff Assay Cartridge and Sample Prep Device. | Portrait Toxigenic C. difficile Assay | GREAT BASIN SCIENTIFIC, INC. |
15 | 30014613336150 | M307 | M307 | Solana C. difficile Assay | Solana | DIAGNOSTIC HYBRIDS, INC. |
16 | 30014613312017 | C. difficile Assay | M201 | AmpliVue CDiff Assay | AmpliVue | QUIDEL CORPORATION |
17 | 30014613311058 | Direct C. difficile Assay | M105 | Lyra Direct CDIFF Assay | Lyra | QUIDEL CORPORATION |
18 | 20816101025613 | MOL5290 | Simplexa™ C.difficile Sample Prep Kit | DIASORIN MOLECULAR LLC | ||
19 | 20816101025606 | MOL2960 | Simplexa™ C. difficile Positive Control Pack | DIASORIN MOLECULAR LLC | ||
20 | 20816101025590 | MOL2950 | Simplexa™ C. difficile Direct | DIASORIN MOLECULAR LLC | ||
21 | 04053228004646 | 1 | 4572346 | artus® C. difficile QS-RGQ MDx Kit | QIAGEN GMBH |