BacT/ALERT®3D 120 Left Combo Module

GUDID 03573026047573

The BacT/ALERT 3D Combination contains an integrated Control and Incubator Module with two left hand configured 60 capacity drawers for a total combined capacity of 120 cells.

BIOMERIEUX , INC.

Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD, automated Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD Blood culture analyser IVD
Primary Device ID03573026047573
NIH Device Record Key23e4cba7-11ac-421d-86b9-da4b8db8399b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBacT/ALERT®3D 120 Left Combo Module
Version Model Number200291
Company DUNS086785110
Company NameBIOMERIEUX , INC.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026047573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDBSystem, blood culturing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-02
Device Publish Date2020-10-23

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Trademark Results [BacT/ALERT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BACT/ALERT
BACT/ALERT
77523447 3962173 Live/Registered
bioMérieux, Inc.
2008-07-16
BACT/ALERT
BACT/ALERT
75022103 2017525 Live/Registered
BIOMERIEUX, INC.
1995-11-20

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