Primary Device ID | 07613336133514 |
NIH Device Record Key | decaedb6-f9c9-4bd6-8b8d-95d1d5dadb8a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ONLINE TDM Amikacin |
Version Model Number | 08105383190 |
Catalog Number | 08105383190 |
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 | 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 |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613336133514 [Primary] |
KLP | AMIKACIN SERUM 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 | 2020-03-13 |
Device Publish Date | 2020-03-05 |
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