FDA.reportPublic FDA data

NucliSENS® easyMAG® DISPOSABLE

Primary DI
03573026139360
Brand
NucliSENS® easyMAG® DISPOSABLE
Company
BIOMERIEUX SA
Model
NucliSENS® easyMAG® DISPOSABLE
Device description
NUCLISENS EASYMAG DISPOSABLE are intended to be used with NucliSENS easyMAG.
Published
2020-04-06
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
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
Pipetting systemAn assembly of devices designed to automatically pipette liquids in the laboratory for the preparation/concentration of analytes (e.g., cells, nucleic acids, microorganisms) in clinical specimens (e.g., blood, urine, sputum, faeces). It is software operated and automatically moves liquids by pipetting, and typically by mixing, heating, and magnetic particle handling. It typically includes a mains electricity (AC-powered) pipetting system, a heating module, shaker, bar-code reader (for specimen traceability), adaptors, grippers, and sample racks. The system is commonly used with specialized kits for the extraction/isolation/concentration of analytes.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
DM exempt
false
Premarket exempt
true
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

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03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
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B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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