FDA.reportPublic FDA data

BACT/ALERT® 3D LEFT INCUBATION MODULE

Primary DI
03573026049577
Brand
BACT/ALERT® 3D LEFT INCUBATION MODULE
Company
BIOMERIEUX , INC.
Model
210159
Device description
the BacT/ALERT 3D Left Incubator Module has four independent drawers of 60 cells each. Patented cell flags track bottle movements between cells for greater ease of use.
Published
2020-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MDBSystem, blood culturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDBSystem, Blood CulturingMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903505000
K981736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903505000BACT/ALERT (TM)Organon Teknika Corp.1991-03-12MDB
K981736000BACT/ALERT 3D MICROBIAL DETECTION SYSTEMOrganon Teknika Corp.1998-07-24MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026049577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026049577035730260495773573026049577

GMDN Terms#

Term, Definition table
TermDefinition
Blood culture analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism. Changes in metabolite production which indicate growth may be detected using radiometric labelled substrate uptake, infrared spectrophotometric detection of CO2, fluorometric detection of fluorescent substrate uptake, photometric detection of turbidity change and/or colorimetric detection of pH induced colour change. It operates with complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
086785110
Device count
1
Serial number
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

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Primary DI, Brand, Company table
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60382904455707BD BACTEC™ 9120BECTON, DICKINSON AND COMPANYMDB2024-11-04
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