FDA.reportPublic FDA data

BACT/ALERT®

Primary DI
03573026616694
Brand
BACT/ALERT®
Company
BIOMERIEUX , INC.
Model
BACT/ALERT®
Device description
Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for enhanced recovery and detection of a variety of anaerobic and facultative microorganisms
Published
2020-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GIMTubes, vacuum sample, with anticoagulant
MDBSystem, blood culturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2
MDBSystem, Blood CulturingMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020931000BACT/ALERT SA CULTURE BOTTLEbioMerieux, Inc.2002-04-18MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026209360PackageGS11In Commercial Distribution
03573026616694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026209360035730262093603573026209360
03573026616694035730266166943573026616694

GMDN Terms#

Term, Definition table
TermDefinition
Blood culture broth kit IVDA collection of two or more bottles containing broth culture medium, with or without additional supplements and/or adsorbent compounds, intended to be used for the collection, preservation, and/or transport of a clinical blood specimen for culture, analysis, and/or other investigation using a manual or automated method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
086785110
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026628116VITEK® 2 AST-XN19VITEK® 2 AST-XN192022-04-15
03573026618285VITEK10.02025-05-15
03573026612047BACT/ALERT® BPABACT/ALERT® BPA2020-06-26
03573026614157BACT/ALERT® BPNBACT/ALERT® BPN2020-06-26
03573026613914VITEK® 2 Knowledge base update 09.039.032022-04-11
03573026615499VITEK® COMPACT PRO4234652025-05-15
03573026222222VITEK® 2 DENSICHEK® Plus Standards Kit212552016-11-30
03573026609399VITEK® 2 Software 09.029.02.02019-06-12
03573026530808VITEK® 2 AST-GP74VITEK® 2 AST-GP742017-01-09
03573026595722BACT/ALERT® PFBACT/ALERT® PF2020-04-22
03573026595906BACT/ALERT® FABACT/ALERT® FA2020-04-23
03573026595920BACT/ALERT® FNBACT/ALERT® FN2020-04-23
03573026222239DENSICHEK® Plus212502016-11-30
03573026530914VITEK® 2 AST-GN68VITEK® 2 AST-GN682017-01-09
03573026647780VITEK® 2 AST-N816VITEK® 2 AST-N8162025-11-21
03573026638887VITEK® REVEAL™ BC GN02-ASTVITEK® REVEAL™ BC GN02-AST2024-10-09
03573026613112PREVI™ Isola Applicator CartrigePREVI™ Isola Applicator Cartrige2020-06-26
03573026145842VITEK®227222R2016-09-14
03573026553968VITEK®28.012017-01-03
03573026619060VITEK®29.01.12019-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00382904453503BD BACTEC™ FXI Culture System Analyzer ModuleBECTON, DICKINSON AND COMPANYMDB2026-06-02
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20192253051183MonojectCardinal Health 200, LLCGIM2024-10-08
50382903666039BD MiniDraw™ H&H Capillary Blood Collection TubeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666138BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666145BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666152BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666169BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666176BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666190BD MiniDraw™ Capillary Tube Adapter H&HBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666172BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
20192253050926MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050940MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050971MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050995MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051008MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051015MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051022MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051039MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051053MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051060MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051077MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051084MonojectCardinal Health 200, LLCGIM2024-02-28