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 | 20816101022155 | EL0910G-5 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
26 | 20816101022148 | EL0910G | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HerpeSelect® 1 ELISA IgG | ||
27 | 10816101025036 | MOL1011-P | OOI | Real Time Nucleic Acid Amplification System | 2 | Integrated Cycler (220V) Pre-Owned | ||
28 | 10816101022349 | EL0351 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Antigen Wells | ||
29 | 10816101022318 | EL0304 | NOP | Elisa, Antibody, West Nile Virus | 2 | West Nile Virus IgG DxSelect™ - IgG Conjugate | ||
30 | 10816101022295 | EL0009 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | DxSelect™ - Substrate Reagent | ||
31 | 10816101022080 | EL0904 | MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | HSV ELISA Negative Control | ||
32 | 20816101025613 | MOL5290 | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | Simplexa™ C.difficile Sample Prep Kit | ||
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 | B540FAB1100CWC0 | FAB1100CW-C | FAB1100CW-1 | The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qua The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test. | Accula Flu A / B Control Kit | MESA BIOTECH, INC. |
2 | B540FAB1100CW0 | FAB1100CW | FAB1100CW | The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. | Accula Flu A / B Test | MESA BIOTECH, INC. |
3 | B540D20010 | D2001 | D2001 | The Programming Cassette is an accessory to the Accula Dock and facilitates repr The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware | Accula Programming Cassette | MESA BIOTECH, INC. |
4 | B540D20000 | D2000 | D2000 | The Accula Dock is an electronic module which executes in vitro diagnostic tests The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of anelectro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary toorchestrate in-vitro diagnostic tests within the inserted Test Cassette. | Accula Dock | MESA BIOTECH, INC. |
5 | B54010400 | 1040 | 1040 | The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro dia The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chainreaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA.The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection.The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinicaland epidemiological risk factors. | Silaris RSV Supplemental Pack | MESA BIOTECH, INC. |
6 | B54010350 | 1035 | 1035 | The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. | Sialris Influenza A&B Supplemental Pack | MESA BIOTECH, INC. |
7 | B54010290 | 1029 | 1029 | The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality c The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test | Silaris RSV Control Kit | MESA BIOTECH, INC. |
8 | B54010280 | 1028 | 1028 | The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location. | SilarisTM Influenza A&B Starter Pack | MESA BIOTECH, INC. |
9 | B54010270 | 1027 | 1027 | The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. | Silaris Influenza A&B Test | MESA BIOTECH, INC. |
10 | B54010240 | 1024 | 1024 | The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use i The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test. | Silaris Influenza A&B Control Kit | MESA BIOTECH, INC. |
11 | 30014613336143 | M306 | M306 | Solana RSV/hMPB Assay | Solana | DIAGNOSTIC HYBRIDS, INC. |
12 | 30014613336068 | M300 | M300 | Solana Infulenza A+B Assay | Solana | DIAGNOSTIC HYBRIDS, INC. |
13 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | Lyra | QUIDEL CORPORATION |
14 | 30014613311034 | M103 | M103 | Lyra RSV+HMPV Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
15 | 30014613311003 | M100 | M100 | Lyra FLU A+B Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
16 | 20816101025552 | MOL2660 | Simplexa™ Flu A/B & RSV Positive Control Pack | DIASORIN MOLECULAR LLC | ||
17 | 20816101025545 | MOL2650 | Simplexa™ Flu A/B & RSV Direct | DIASORIN MOLECULAR LLC | ||
18 | 20816101025538 | MOL2600 | Simplexa™ Flu A/B & RSV | DIASORIN MOLECULAR LLC | ||
19 | 15420045509320 | AMR CTRLS, PANTHER FUSION, IVD | PRD-04338 | PANTHER FUSION | HOLOGIC, INC. | |
20 | 15420045509313 | FLU A B RSV CTRLS, PANTHER FUSION, IVD | PRD-04336 | PANTHER FUSION | HOLOGIC, INC. | |
21 | 15420045509290 | AMR KIT, PANTHER FUSION, 96T, IVD | PRD-04330 | PANTHER FUSION | HOLOGIC, INC. | |
22 | 15420045509283 | FLU A B RSV, PANTHER FUSION, 96T, IVD | PRD-04328 | PANTHER FUSION | HOLOGIC, INC. | |
23 | 15420045509276 | OIL KIT, PANTHER FUSION, 1920T, IVD | PRD-04335 | PANTHER FUSION | HOLOGIC, INC. | |
24 | 15420045509269 | ELUTION KIT, PANTHER FUSION, 2400T, IVD | PRD-04334 | PANTHER FUSION | HOLOGIC, INC. | |
25 | 15420045509252 | RECON-1 KIT, PANTHER FUSION, 1920T, IVD | PRD-04333 | PANTHER FUSION | HOLOGIC, INC. | |
26 | 15420045509238 | SPECIMEN LYSIS TUBES, IVD | PRD-04339 | PANTHER FUSION | HOLOGIC, INC. | |
27 | 15420045509221 | INTERNAL CONTROL-S, 960T, IVD | PRD-04332 | PANTHER FUSION | HOLOGIC, INC. | |
28 | 15420045509214 | EXTRACTION REAGENT-S, 960T, IVD | PRD-04331 | PANTHER FUSION | HOLOGIC, INC. | |
29 | 15420045506381 | PROADENO+ KIT, 100 REACTIONS | 303675 | PRODESSE | HOLOGIC, INC. | |
30 | 15420045506343 | PROFLU+ ASSAY KIT, 1,500 REACTIONS | 303123 | PRODESSE | HOLOGIC, INC. | |
31 | 15420045506336 | PROFLU+ ASSAY KIT, 2,000 REACTIONS | 303121 | PRODESSE | HOLOGIC, INC. | |
32 | 15420045506329 | PRODESSE PROFLU+ ASSAY | 303111 | PRODESSE | HOLOGIC, INC. | |
33 | 15415219000635 | 1.0 | A1030/6 | Idylla™ Respiratory (IFV-RSV) Panel | BIOCARTIS NV | |
34 | 07613336129685 | 08085463001 | 08085463001 | cobas® Liat® Influenza A/B Script | ROCHE MOLECULAR SYSTEMS, INC. | |
35 | 07332940006044 | XPRSFLU-10 | XPRSFLU-10 | Xpert Xpress Flu kit; 10 test kit | Xpert Xpress Flu | CEPHEID |
36 | 07332940005696 | XPRSFLU/RSV-10 | XPRSFLU/RSV-10 | Xpert Xpress Flu/RSV kit; 10 test kit | Xpert Xpress Flu/RSV | CEPHEID |
37 | 07332940005177 | GXFLU+RSV-XP-10 | GXFLU+RSV-XP-10 | Xpert Flu+RSV Xpress kit; 10 test kit | Xpert Flu+RSV Xpress | CEPHEID |
38 | 07332940001070 | GXFLU-10A | GXFLU-10A | Xpert Flu kit; 10 test kit | Xpert Flu | CEPHEID |
39 | 07332940000783 | GXFLU/RSV-10 | GXFLU/RSV-10 | Xpert FLU/RSV XC kit; 10 test kit | Xpert FLU/RSV XC | CEPHEID |
40 | 04053228033905 | V1 | 691221 | QIAstat-Dx® Respiratory Panel | QIAGEN GMBH | |
41 | 03573026403997 | 69-010B-US | ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respira ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings. | ARGENE® ADENOVIRUS R-gene KIT US | BIOMERIEUX SA | |
42 | 00875197005950 | 08160104190 | 08160104190 | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
43 | 00875197005653 | 07402686190 | 07402686190 | cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
44 | 00875197005639 | 07402660190 | 07402660190 | cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
45 | 00875197005608 | 07341890190 | 07341890190 | cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
46 | 00857573006324 | 20-011-024 | The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. | Respiratory Pathogens Flex (RP Flex) Amplification Tray | NANOSPHERE, INC. | |
47 | 00857573006294 | 20-011-020 | The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. | Respiratory Virus Plus (RV+) Amplification Tray | NANOSPHERE, INC. | |
48 | 00857573006263 | 20-009-024 | The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. | Respiratory Pathogens Flex (RP Flex) Extraction Tray | NANOSPHERE, INC. | |
49 | 00857573006232 | 20-009-020 | The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. | Respiratory Virus Plus (RV+) Extraction Tray | NANOSPHERE, INC. | |
50 | 00857573006164 | 20-006-024 | The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. | Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge | NANOSPHERE, INC. |