BACT/ALERT® PF PLUS

GUDID 03573026357924

The BACT/ALERT PF Plus Culture Bottles are used for recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast) from blood.

BIOMERIEUX , INC.

Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD Basic/simple nutrient broth culture medium IVD
Primary Device ID03573026357924
NIH Device Record Key0a407d92-bc25-4b50-bd30-c5af3e68ae6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBACT/ALERT® PF PLUS
Version Model NumberBACT/ALERT® PF PLUS
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
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026357924 [Package]
Contains: 03573026611910
Package: [2 Units]
In Commercial Distribution
GS103573026596095 [Primary]
GS103573026611910 [Package]
Contains: 03573026596095
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.

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
03573026636319 - VITEK® 2 AST-N8132023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636333 - VITEK® 2 AST-XN332023-11-10 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636128 - VITEK® 2 AST-N8102023-11-09 VITEK® 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems to determine the susceptibility of clin
03573026636067 - VITEK® 2 AST-N8042023-10-04 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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