FDA.reportPublic FDA data

BACT/ALERT® MP

Primary DI
03573026611798
Brand
BACT/ALERT® MP
Company
BIOMERIEUX , INC.
Model
BACT/ALERT MP
Device description
Mycobacteria Detection bottle for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.
Published
2020-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
K190405000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190405000BACT/ALERT MP Reagent SystembioMerieux, Inc.2019-05-15MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026506063PackageGS12In Commercial Distribution
03573026611798PackageGS150In Commercial Distribution
03573026596163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026506063035730265060633573026506063
03573026611798035730266117983573026611798
03573026596163035730265961633573026596163

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective broth culture medium IVDA broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00382904453497BD BACTEC™ FXI Culture System Workflow ModuleBECTON, DICKINSON AND COMPANYMDB2026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer ModuleBECTON, DICKINSON AND COMPANYMDB2026-06-02
00382902451228BD BACTEC™ MGIT™ Mycobacteria Growth Indicator TubesBECTON, DICKINSON AND COMPANYMDB2026-01-07
00382904422882BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
60382904422884BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
00848838091841VersaTREK™ REMEL, INC.MDB2025-01-16
00848838091742VersaTREK™ REMEL, INC.MDB2025-01-16
00382904454753BD BACTEC™ 9240BECTON, DICKINSON AND COMPANYMDB2024-11-04
00382904455705BD BACTEC™ 9120BECTON, DICKINSON AND COMPANYMDB2024-11-04
60382904454755BD BACTEC™ 9240BECTON, DICKINSON AND COMPANYMDB2024-11-04
60382904455707BD BACTEC™ 9120BECTON, DICKINSON AND COMPANYMDB2024-11-04
00382904458003BD BACTEC™ 9050BECTON, DICKINSON AND COMPANYMDB2024-11-01
00382904458713BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
00382904459994BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
00382904413705BD BACTEC™ Digital ThermometerBECTON, DICKINSON AND COMPANYMDB2024-08-22
00848838096747VERSATREK M 528 W/22 DRAWERSREMEL, INC.MDB2023-09-19
03573026629649BACT/ALERTBIOMERIEUX , INC.MDB2023-09-15
00848838096327VERSATREK 528 W/22 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096471VERSATREK 240 W/6 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-26
00848838096501VERSATREK 240 W/8 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096518VERSATREK 240 W/8 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-26
00848838096549VERSATREK 240 W/10 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096556VERSATREK 240 W/10 DR/CTRL MOD 220VREMEL, INC.MDB2023-07-26
00848838096570VERSATREK 528 W/14 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096617 VERSATREK 528 W/16 DRAWERS/CTRL MOD REMEL, INC.MDB2023-07-26
00848838096655VERSATREK 528 W/18 DRAWERS/CTRL MOD REMEL, INC.MDB2023-07-26
00848838096662VERSATREK 528 W/18 DR/CTRL MOD 220VREMEL, INC.MDB2023-07-26
00848838096693VERSATREK 528 W/20 DRAWERS/CTRL MREMEL, INC.MDB2023-07-26
00848838096426VERSATREK 240 W/4 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-25
00848838096433 VERSATREK 240 W/4 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-25