cobas® vivoDx MRSA 08380180190

GUDID 00875197006193

Roche Molecular Systems, Inc.

MRSA phenotype detection IVD, kit, bioassay
Primary Device ID00875197006193
NIH Device Record Keyfeae947e-0428-4876-b66e-0bcea2a64777
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas® vivoDx MRSA
Version Model Number08380180190
Catalog Number08380180190
Company DUNS071674100
Company NameRoche Molecular Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197006193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIVCulture-based short-term incubation antimicrobial resistance assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-23
Device Publish Date2020-01-15

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