BACT/ALERT® BPN

Primary DI
03573026126735
Brand
BACT/ALERT® BPN
Company
BIOMERIEUX , INC.
Model
BACT/ALERT® BPN
Device description
BacT/ALERT BPN (anaerobic culture) bottles: used for QC testing of leukocyte reduced apheresis platelet units,leukocyte reduced single units of whole blood platelet concentrates.
Published
2020-04-27
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
MZCSystem, detection, bacterial, for platelet transfusion products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZCSystem, Detection, Bacterial, For Platelet Transfusion ProductsMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK050043000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK050043000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026126735PackageGS12In Commercial Distribution
03573026611866PackageGS150In Commercial Distribution
03573026595999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026126735035730261267353573026126735
03573026611866035730266118663573026611866
03573026595999035730265959993573026595999

GMDN Terms#

Term, Definition table
TermDefinition
Basic/simple nutrient broth culture medium IVDA non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.

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
00382904420536BD BACTEC™ Platelet Aerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
00382904420543BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
30382904420537BD BACTEC™ Platelet Aerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
30382904420544BD BACTEC™ Platelet Anaerobic/F Culture VialsBECTON, DICKINSON AND COMPANYMZC2023-10-05
10850046056069Platelet PGDprime Sample PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056076Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056083Platelet PGDprime Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056090Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056021Platelet PGDprime Reagent 1BVerax Biomedical IncorporatedMZC2023-04-19
10850046056250Platelet PGDprime Sample PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056243Platelet PGDprime Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056236Platelet PGDprime Processing TubesVerax Biomedical IncorporatedMZC2023-04-19
10850046056113Platelet PGDprime Test, 20 devices plus disposablesVerax Biomedical IncorporatedMZC2023-04-19
10850046056120Platelet PGDprime Sample Pipettes, Processing Tubes and Transfer PipettesVerax Biomedical IncorporatedMZC2023-04-19
10850046056137Platelet PGDprime Reagents, 100 TestVerax Biomedical IncorporatedMZC2023-04-19
10850046056144Platelet PGDprime Reagents, 20 TestVerax Biomedical IncorporatedMZC2023-04-19
10850046056007Platelet PGDprime TestVerax Biomedical IncorporatedMZC2023-04-17
10850046056014Platelet PGDprime Reagent 1AVerax Biomedical IncorporatedMZC2023-04-13
10850046056038Platelet PGDprime Reagent 2Verax Biomedical IncorporatedMZC2023-04-13
03573026612047BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-06-26
03573026614157BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-06-26
03573026614140BACT/ALERT®BIOMERIEUX , INC.MZC2020-06-26
03573026611323BACT/ALERT®BIOMERIEUX , INC.MZC2020-06-26
03573026595975BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-04-27
03573026595999BACT/ALERT® BPNBIOMERIEUX , INC.MZC2020-04-27
03573026126742BACT/ALERT® BPABIOMERIEUX , INC.MZC2020-04-27
20887691306376HaemoneticsHAEMONETICS CORPORATIONMZC2017-03-20
30887691306373HaemoneticsHAEMONETICS CORPORATIONMZC2017-03-20