No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 15420045515031 | 2050-0104 | 2050-0104 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
2 | 15420045514089 | R15 | R15 | GDF | GUIDE, NEEDLE, SURGICAL | 1 | PERL | |
3 | 15420045506909 | Discovery C | KGI | Densitometer, bone | 2 | Discovey C | ||
4 | 15420045504110 | ATEC Sapphire 200 | KNW | INSTRUMENT, BIOPSY | 2 | ATEC Sapphire 200 | ||
5 | 15420045510333 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
6 | 15420045514294 | V5 | NSV5US-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
7 | 25420045510330 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
8 | 25420045514307 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
9 | 25420045505107 | 40-902 | 40-902 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
10 | 15420045514836 | PATHVISION 23x29 | PATHVISION23X29 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
11 | 15420045514300 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
12 | 15420045512924 | INTERNAL CONTROL-B, 960T, IVD | PRD-06234 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
13 | 15420045512917 | EXTRACTION REAGENTS-B, 960T, IVD | PRD-06232 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
14 | 15420045510906 | GBS CTRLS KIT, PANTHER FUSION, IVD | PRD-04485 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
15 | 15420045510890 | GBS KIT, 96T, IVD | PRD-04484 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
16 | 15420045510470 | INTERNAL CONTROL-X, 960T, IVD | PRD-04476 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
17 | 15420045510463 | EXTRACTION REAGENT-X, 960T, IVD | PRD-04477 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
18 | 15420045509641 | System Software | InSight FD | OXO | Image-intensified fluoroscopic x-ray system, mobile | 2 | Flouroscan InSight | |
19 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | aptima | |
20 | 15420045507937 | 20-401ML | 20-401ML | NWW | Hysteroscope accessories | Myosure Manual Tissue Removal Device | ||
21 | 15420045505230 | B90003 | B90003 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4.0-5.0 CM CT LUMEN MARKER SET | |
22 | 15420045505193 | B11245 | B11245 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER | |
23 | 15420045505094 | 50-501XL | 50-501XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
24 | 15420045505087 | 50-401XL | 50-401XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
25 | 15420045505070 | 30-401LITE | 30-401LITE | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
26 | 15420045505001 | 919007-01 | 919007-01 | JAQ | System, applicator, radionuclide, remote-controlled | Mammosite Variable 4-5 cm Applicator Tray | ||
27 | 15420045504998 | EVIVA_1213-20 | EVIVA_1213-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_1213-20 | ||
28 | 15420045504950 | EVIVA_0910-20 | EVIVA_0910-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_0910-20 | ||
29 | 15420045504813 | 10-401 | 10-401 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
30 | 15420045501140 | 2000 | NS2000US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
31 | 15420045501133 | 2007 | NS2007US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
32 | 15420045501126 | 2013 | NS2013KITUS | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
33 | 15420045501119 | 2013 | NS2013US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
34 | 15420045501065 | Cervista HTA System Computer | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
35 | 15420045500969 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
36 | 15420045500952 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
37 | 15420045500860 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
38 | 15420045500853 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
39 | 15420045512474 | GENIUS AI DETECTION SOFTWARE | OTE | Digital breast tomosynthesis | 3 | GENIUS AI DETECTION | ||
40 | 25420045510064 | FILTER, THINPREP UROCYTE 100 PACK | 70472-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
41 | 25420045510057 | THINPREP SLIDES UROCYTE, 100 pk | 70471-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
42 | 25420045509990 | THINPREP MICROSCOPE, ARCLESS, 72pk | 70126-002 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
43 | 25420045509679 | NON-GYN Slides | 70372-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
44 | 25420045509662 | NON-GYN Filters, 100 pack | 70205-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
45 | 25420045508467 | UroCyte Vial | 70473-001 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
46 | 25420045505039 | 819001 | 819001 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Neucletron HDR Afterloader Connectors wObturators | |
47 | 15420045514775 | PRESERVCYT VIAL | PRD-07129 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
48 | 15420045514621 | UroCyte Vial | ASY-15509 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
49 | 15420045514614 | CytoLyt Cup | PRD-07065 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
50 | 15420045514607 | CytoLyt Tube | PRD-07064 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00815381020161 | RFIT-ASY-0130 | RFIT-ASY-0130 | IVD reagent kit containing 6 tests | FilmArray® Respiratory Panel 2 (RP2) | BIOFIRE DIAGNOSTICS, LLC |
2 | 00815381020154 | RFIT-ASY-0129 | RFIT-ASY-0129 | IVD reagent kit containing 30 tests | FilmArray® Respiratory Panel 2 (RP2) | BIOFIRE DIAGNOSTICS, LLC |
3 | 00815381020147 | RFIT-ASY-0120 | RFIT-ASY-0120 | IVD reagent kit containing 30 tests. | FilmArray® Respiratory Panel (RP) EZ | BIOFIRE DIAGNOSTICS, LLC |
4 | 00815381020079 | RFIT-ASY-0125 | RFIT-ASY-0125 | IVD reagent kit containing 6 tests. | FilmArray® Respiratory Panel (RP) | BIOFIRE DIAGNOSTICS, LLC |
5 | 00815381020062 | RFIT-ASY-0124 | RFIT-ASY-0124 | IVD reagent kit containing 30 tests. | FilmArray® Respiratory Panel (RP) | BIOFIRE DIAGNOSTICS, LLC |
6 | 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. |
7 | 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. |
8 | 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. |
9 | 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. |
10 | 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. |
11 | 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. |
12 | 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. |
13 | 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. |
14 | 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. |
15 | 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. |
16 | 30014613336143 | M306 | M306 | Solana RSV/hMPB Assay | Solana | DIAGNOSTIC HYBRIDS, INC. |
17 | 30014613336068 | M300 | M300 | Solana Infulenza A+B Assay | Solana | DIAGNOSTIC HYBRIDS, INC. |
18 | 30014613311133 | Adenovirus Assay | M113 | Lyra Adenovirus Assay | Lyra | QUIDEL CORPORATION |
19 | 30014613311034 | M103 | M103 | Lyra RSV+HMPV Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
20 | 30014613311003 | M100 | M100 | Lyra FLU A+B Assay | Lyra | DIAGNOSTIC HYBRIDS, INC. |
21 | 20816101025552 | MOL2660 | Simplexa™ Flu A/B & RSV Positive Control Pack | DIASORIN MOLECULAR LLC | ||
22 | 20816101025545 | MOL2650 | Simplexa™ Flu A/B & RSV Direct | DIASORIN MOLECULAR LLC | ||
23 | 20816101025538 | MOL2600 | Simplexa™ Flu A/B & RSV | DIASORIN MOLECULAR LLC | ||
24 | 15420045509320 | AMR CTRLS, PANTHER FUSION, IVD | PRD-04338 | PANTHER FUSION | HOLOGIC, INC. | |
25 | 15420045509313 | FLU A B RSV CTRLS, PANTHER FUSION, IVD | PRD-04336 | PANTHER FUSION | HOLOGIC, INC. | |
26 | 15420045509290 | AMR KIT, PANTHER FUSION, 96T, IVD | PRD-04330 | PANTHER FUSION | HOLOGIC, INC. | |
27 | 15420045509283 | FLU A B RSV, PANTHER FUSION, 96T, IVD | PRD-04328 | PANTHER FUSION | HOLOGIC, INC. | |
28 | 15420045509276 | OIL KIT, PANTHER FUSION, 1920T, IVD | PRD-04335 | PANTHER FUSION | HOLOGIC, INC. | |
29 | 15420045509269 | ELUTION KIT, PANTHER FUSION, 2400T, IVD | PRD-04334 | PANTHER FUSION | HOLOGIC, INC. | |
30 | 15420045509252 | RECON-1 KIT, PANTHER FUSION, 1920T, IVD | PRD-04333 | PANTHER FUSION | HOLOGIC, INC. | |
31 | 15420045509238 | SPECIMEN LYSIS TUBES, IVD | PRD-04339 | PANTHER FUSION | HOLOGIC, INC. | |
32 | 15420045509221 | INTERNAL CONTROL-S, 960T, IVD | PRD-04332 | PANTHER FUSION | HOLOGIC, INC. | |
33 | 15420045509214 | EXTRACTION REAGENT-S, 960T, IVD | PRD-04331 | PANTHER FUSION | HOLOGIC, INC. | |
34 | 15420045506381 | PROADENO+ KIT, 100 REACTIONS | 303675 | PRODESSE | HOLOGIC, INC. | |
35 | 15420045506343 | PROFLU+ ASSAY KIT, 1,500 REACTIONS | 303123 | PRODESSE | HOLOGIC, INC. | |
36 | 15420045506336 | PROFLU+ ASSAY KIT, 2,000 REACTIONS | 303121 | PRODESSE | HOLOGIC, INC. | |
37 | 15420045506329 | PRODESSE PROFLU+ ASSAY | 303111 | PRODESSE | HOLOGIC, INC. | |
38 | 15415219000635 | 1.0 | A1030/6 | Idylla™ Respiratory (IFV-RSV) Panel | BIOCARTIS NV | |
39 | 07613336129685 | 08085463001 | 08085463001 | cobas® Liat® Influenza A/B Script | ROCHE MOLECULAR SYSTEMS, INC. | |
40 | 07332940006044 | XPRSFLU-10 | XPRSFLU-10 | Xpert Xpress Flu kit; 10 test kit | Xpert Xpress Flu | CEPHEID |
41 | 07332940005696 | XPRSFLU/RSV-10 | XPRSFLU/RSV-10 | Xpert Xpress Flu/RSV kit; 10 test kit | Xpert Xpress Flu/RSV | CEPHEID |
42 | 07332940005177 | GXFLU+RSV-XP-10 | GXFLU+RSV-XP-10 | Xpert Flu+RSV Xpress kit; 10 test kit | Xpert Flu+RSV Xpress | CEPHEID |
43 | 07332940001070 | GXFLU-10A | GXFLU-10A | Xpert Flu kit; 10 test kit | Xpert Flu | CEPHEID |
44 | 07332940000783 | GXFLU/RSV-10 | GXFLU/RSV-10 | Xpert FLU/RSV XC kit; 10 test kit | Xpert FLU/RSV XC | CEPHEID |
45 | 04053228033905 | V1 | 691221 | QIAstat-Dx® Respiratory Panel | QIAGEN GMBH | |
46 | 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 | |
47 | 00875197005950 | 08160104190 | 08160104190 | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
48 | 00875197005653 | 07402686190 | 07402686190 | cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
49 | 00875197005639 | 07402660190 | 07402660190 | cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
50 | 00875197005608 | 07341890190 | 07341890190 | cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. |