Primary Device ID | 00365702702127 |
NIH Device Record Key | dc4533b4-1c65-4f8a-97f2-44ea0a9a8d6a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROMA Calculation Tool Using Elecsys Assay |
Version Model Number | 07113358001 |
Catalog Number | 07113358001 |
Company DUNS | 315028860 |
Company Name | Roche Diagnostics GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00365702702127 [Primary] |
ONX | ovarian adnexal mass assessment score test system |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-11-08 |
Device Publish Date | 2016-10-28 |
04015630037025 - cobas b 123 Fluid Pack 400 | 2024-08-07 |
04015630037032 - cobas b 123 Fluid Pack 700 | 2024-08-07 |
04015630037049 - cobas b 123 Fluid Pack 200 | 2024-08-07 |
04015630037636 - cobas b 123 Fluid Pack COOX 200 | 2024-08-07 |
04015630037643 - cobas b 123 Fluid Pack COOX 400 | 2024-08-07 |
04015630037650 - cobas b 123 Fluid Pack COOX 700 | 2024-08-07 |
07613336170304 - Elecsys PTH | 2024-08-07 E2G 300 count |
07613336170311 - CalSet PTH | 2024-08-07 |