FDA.reportPublic FDA data

NUCLISENS® easyMAG® Disposables

Primary DI
03573026616618
Brand
NUCLISENS® easyMAG® Disposables
Company
BIOMERIEUX SA
Model
NUCLISENS® easyMAG® Disposables
Device description
NUCLISENS EASYMAG DISPOSABLE are intended to be used with NucliSENS easyMAG.
Published
2020-04-06
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
JJHCLINICAL SAMPLE CONCENTRATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026139360PackageGS148In Commercial Distribution
03573026616618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026139360035730261393603573026139360
03573026616618035730266166183573026616618

GMDN Terms#

Term, Definition table
TermDefinition
Pipette tip IVDA device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette, or a dispenser, and where the required volume of liquid (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard automated liquid handling instruments or analysers. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
276816717
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
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Primary DI, Brand, Company table
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