ONLINE TDM Tobramycin 08253161190

GUDID 07613336147948

Roche Diagnostics GmbH

Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07613336147948
NIH Device Record Key44417ce3-44b1-4f72-aee6-99339e435f69
Commercial Distribution StatusIn Commercial Distribution
Brand NameONLINE TDM Tobramycin
Version Model Number08253161190
Catalog Number08253161190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336147948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLBRADIOIMMUNOASSAY, TOBRAMYCIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-13
Device Publish Date2020-03-05

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