ONLINE DAT Methaqualone 08814708190

GUDID 07613336166109

Roche Diagnostics GmbH

Methaqualone IVD, reagent
Primary Device ID07613336166109
NIH Device Record Key9348a35c-10b9-490f-87ac-8759d0ea8442
Commercial Distribution StatusIn Commercial Distribution
Brand NameONLINE DAT Methaqualone
Version Model Number08814708190
Catalog Number08814708190
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
GS107613336166109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXSRadioimmunoassay, methaqualone

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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