ONLINE TDM Methotrexate 09230815190

GUDID 07613336224823

Roche Diagnostics GmbH

Methotrexate therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07613336224823
NIH Device Record Keya77a73cf-7181-49a3-8d5b-1f9308a39f9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameONLINE TDM Methotrexate
Version Model Number09230815190
Catalog Number09230815190
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336224823 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAOEnzyme immunoassay, methotrexate

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [ONLINE TDM Methotrexate ]

0761333622482309230815190
0761333622481609230785190

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