No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00869164000024 | 404-10US | ROMA (HE4 EIA + ARCHITECT CA125II) Software disk | ONX | Ovarian Adnexal Mass Assessment Score Test System | 2 | ROMA | |
2 | 00869164000000 | 801-905 | OAW | Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/ Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma | MESOMARK |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00380740146269 | 03R7521 | 03R7521 | Alinity i ROMA | Alinity | ABBOTT GMBH |
2 | 00380740138738 | 6P30-21 | 06P3021 | ARCHITECT ROMA | ARCHITECT | ABBOTT LABORATORIES |
3 | 00365702702127 | 07113358001 | 07113358001 | ROMA Calculation Tool Using Elecsys Assay | ROCHE DIAGNOSTICS GMBH | |
4 | 00869164000024 | 404-10US | ROMA (HE4 EIA + ARCHITECT CA125II) Software disk | ROMA | FUJIREBIO DIAGNOSTICS, INC. | |
5 | 00869164000017 | CL0004 | Software Disk | Lumipulse G ROMA | FUJIREBIO DIAGNOSTICS, INC. | |
6 | 00860942000113 | 3.0.3.006 | Ova1® is a qualitative serum test that combines the results of five immunoassays Ova1® is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. Ova1® is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay. | OVA1 | VERMILLION, INC. |