Primary Device ID | 07613336231364 |
NIH Device Record Key | 8776eed0-ff6b-4781-b7d9-e11ac5bec2ef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | cobas i 601 |
Version Model Number | 10271582001 |
Catalog Number | 10271582001 |
Company DUNS | 315028860 |
Company Name | Roche Diagnostics GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
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 | 07613336231364 [Primary] |
DOP | MASS SPECTROMETER, CLINICAL USE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-08 |
Device Publish Date | 2025-07-31 |
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