FDA.reportPublic FDA data

NUCLISENS® easyMAG® SOFTWARE V2. 1

Primary DI
03573026448301
Brand
NUCLISENS® easyMAG® SOFTWARE V2. 1
Company
BIOMERIEUX SA
Model
2.1
Device description
EASYMAG SOFTWARE V2.1 : virtual reference
Published
2020-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
03573026448301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026448301035730264483013573026448301

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
Premarket exempt
true

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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
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
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04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
00849811081835Maxwell® CSC Rapid ccfDNA KitPROMEGA CORPORATIONJJH2026-02-16
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04719882810282IntelliPrep FFPE RNA Extraction KitPlexBio Co., Ltd.JJH2026-01-28
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