ONLINE TDM Amikacin 08105383190

GUDID 07613336133514

Roche Diagnostics GmbH

Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry
Primary Device ID07613336133514
NIH Device Record Keydecaedb6-f9c9-4bd6-8b8d-95d1d5dadb8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameONLINE TDM Amikacin
Version Model Number08105383190
Catalog Number08105383190
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
GS107613336133514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLPAMIKACIN SERUM ASSAY

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

Devices Manufactured by Roche Diagnostics GmbH

07613336217665 - Elecsys Total PSA2024-11-01
07613336217672 - Elecsys free PSA2024-11-01
07613336218440 - Elecsys Rubella IgM2024-11-01
07613336217146 - Elecsys AFP2024-10-30
07613336218426 - Elecsys Prolactin II2024-10-16
07613336160367 - Elecsys Anti-HBs II2024-10-10
07613336230367 - Elecsys Anti-HBs II2024-08-28
07613336217801 - Elecsys FSH2024-08-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.