FDA.reportPublic FDA data

CARTUCCIA CON 36 POZZETTI/36-WELLS CARTRIDGE

Primary DI
08057507430030
Brand
CARTUCCIA CON 36 POZZETTI/36-WELLS CARTRIDGE
Company
HYRIS SRL
Model
HyCT36.01-25
Catalog number
HyCT36.01-25
Device description
PCR Cartridge.
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NSUInstrumentation For Clinical Multiplex Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSUInstrumentation For Clinical Multiplex Test SystemsClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057507430030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057507430030080575074300308057507430030

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/analyser specimen/reagent container carrier IVDA device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
441725600
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057507430009bCUBE bCUBE 2.0 bCUBE 2.0 2023-03-21
08057507430023CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGEHyCT16.01-25HyCT16.01-252023-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060441760005binx ioBINX HEALTH LIMITEDNSU2025-09-03
10190302019897Applied BioSystems™ ABY™ Dye Spectral Calibration Plate for Multiplex qPCR, FastLIFE TECHNOLOGIES HOLDINGS PTE. LTD.NSU2025-08-19
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15420045517059Aptima®Hologic, Inc.NSU2024-12-19
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00840487101964LIAISON PLEX® Chassis (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
00840487101971LIAISON PLEX® ModuleLUMINEX CORPORATIONNSU2024-06-20
00840487101988LIAISON PLEX® Module (Refurbished)LUMINEX CORPORATIONNSU2024-06-20
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00851458005297FILMARRAY® COMMERCIAL LAPTOPBIOFIRE DEFENSE, LLCNSU2024-03-19
00195126000871Aptiva® System Cleaning Solution KitINOVA DIAGNOSTICS, INC.NSU2024-03-18
00195126000741Aptiva® Instrument System CuvettesINOVA DIAGNOSTICS, INC.NSU2024-03-11