cobas Buffer Negative Control Kit 09051953190

GUDID 00875197006926

Roche Diagnostics GmbH

PCR/NAT negative control IVD
Primary Device ID00875197006926
NIH Device Record Key4869f3e5-0323-4e9a-9d82-67da2509b773
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas Buffer Negative Control Kit
Version Model Number09051953190
Catalog Number09051953190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197006926 [Primary]

FDA Product Code

NSUInstrumentation for clinical multiplex test systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-13
Device Publish Date2024-06-05

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