BACT/ALERT® SA

GUDID 03573026611781

The BACT/ALERT SA Culture Bottles are used for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.

BIOMERIEUX , INC.

Basic/simple nutrient broth culture medium IVD
Primary Device ID03573026611781
NIH Device Record Key7c2e4ae1-b45e-4d65-8365-9b5c6fb84f79
Commercial Distribution StatusIn Commercial Distribution
Brand NameBACT/ALERT® SA
Version Model NumberBACT/ALERT® SA
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 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 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026055806 [Package]
Package: [2 Units]
In Commercial Distribution
GS103573026595739 [Primary]
GS103573026611781 [Package]
Contains: 03573026595739
Package: [50 Units]
In Commercial Distribution

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 Date2020-05-01
Device Publish Date2020-04-23

Devices Manufactured by BIOMERIEUX , INC.

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00860007326912 - VITEK® REVEAL™ SEALER2024-10-17 The VITEK REVEAL SEALER provides the heat welding of the VITEK REVEAL SENSOR PANEL to the 96 well AST Drug Plate.
03573026638900 - VITEK® REVEAL™ SENSOR PANEL2024-10-17 The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria
03573026636357 - VITEK® 2 AST-N8142023-12-14 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026635978 - VITEK® 2 AST-N8092023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636142 - VITEK® 2 AST-N8112023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636296 - VITEK® 2 AST-N8122023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin

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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