CHROMID® VRE Agar

GUDID 03573026313128

Chromogenic medium for the qualitative detection of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE) in stool specimens.

BIOMERIEUX SA

Differential/selective agar culture medium IVD
Primary Device ID03573026313128
NIH Device Record Keyf76c562d-1705-47cd-ade2-af147f894656
Commercial Distribution StatusIn Commercial Distribution
Brand NameCHROMID® VRE Agar
Version Model NumberchromID™ VRE Agar
Company DUNS276816717
Company NameBIOMERIEUX SA
Device Count10
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
GS103573026313128 [Package]
Contains: 03573026552138
Package: [2 Units]
In Commercial Distribution
GS103573026552138 [Primary]
GS103573026552145 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-14
Device Publish Date2016-09-23

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03573026624545 - ETEST® Tobramycin (TM)2023-12-28 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an
03573026613808 - ETEST® Sulbactam/Durlobactam (SUD)2023-12-26 ETEST® is a manual, quantitative technique for determination of antimicrobial susceptibility of non-fastidious Gram-negative an
03573026628154 - VITEK® MS knowledge base v3.32023-11-22 VITEK® MS knowledge base v3.3
03573026073916 - Food Culture media2023-09-08 Selective isolation of Escherichia coli O157 :H7, and, for industrial applications only, enterohemorrhagic E. coli
03573026617622 - VIDAS® 3 SOFTWARE V1.42023-07-12 VIDAS 3 V1.4 Software

Trademark Results [CHROMID]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHROMID
CHROMID
86591765 4986430 Live/Registered
bioMérieux
2015-04-09

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