FDA.reportPublic FDA data

PREVI™ Isola Applicator Cartrige

Primary DI
03573026613112
Brand
PREVI™ Isola Applicator Cartrige
Company
BIOMERIEUX , INC.
Model
PREVI™ Isola Applicator Cartrige
Device description
PREVI ISOLA APPLICATORS CARTRIDGE
Published
2020-06-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026219680PackageGS18Not in Commercial Distribution
03573026613112PrimaryGS10
03573026612863Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026219680035730262196803573026219680
03573026613112035730266131123573026613112
03573026612863035730266128633573026612863

GMDN Terms#

Term, Definition table
TermDefinition
Inoculating tool IVD, analyser/instrumentA component of an automated/semi-automated in vitro diagnostic laboratory analyser or instrument intended to be used onboard to collect, transfer and spread an inoculum from a clinical specimen and/or culture isolate onto/into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It is typically made of sterilizable materials (e.g., plastic, metal) and consists of a shaft with a loop, wand, or swab at one or both ends. This is a reusable device.

Regulatory Flags#

DUNS number
086785110
Device count
120
Premarket exempt
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
03573026145842VITEK®227222R2016-09-14
03573026553968VITEK®28.012017-01-03
03573026619060VITEK®29.01.12019-08-27
03573026641320VITEK® 2 AST-N815VITEK® 2 AST-N8152024-11-13

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Primary DI, Brand, Company table
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20885380197861CARDINAL HEALTHCardinal Health 200, LLCLXG2025-04-18