Primary Device ID | 00875197006193 |
NIH Device Record Key | feae947e-0428-4876-b66e-0bcea2a64777 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | cobas® vivoDx MRSA |
Version Model Number | 08380180190 |
Catalog Number | 08380180190 |
Company DUNS | 071674100 |
Company Name | Roche Molecular Systems, Inc. |
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 | true |
Device Combination Product | false |
Single Use | true |
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 | 00875197006193 [Primary] |
QIV | Culture-based short-term incubation antimicrobial resistance assay |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-01-23 |
Device Publish Date | 2020-01-15 |
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