CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE HyCT16.01-25

GUDID 08057507430023

PCR Cartridge.

HYRIS SRL

Instrument/analyser specimen/reagent container carrier IVD
Primary Device ID08057507430023
NIH Device Record Keybe6319ba-dd60-491c-baa8-fe882bd02581
Commercial Distribution StatusIn Commercial Distribution
Brand NameCARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE
Version Model NumberHyCT16.01-25
Catalog NumberHyCT16.01-25
Company DUNS441725600
Company NameHYRIS SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108057507430023 [Primary]

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-29
Device Publish Date2023-03-21

Devices Manufactured by HYRIS SRL

08057507430009 - bCUBE 2023-03-29 Real-time PCR instrument.
08057507430023 - CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE2023-03-29PCR Cartridge.
08057507430023 - CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE2023-03-29 PCR Cartridge.
08057507430030 - CARTUCCIA CON 36 POZZETTI/36-WELLS CARTRIDGE2023-03-29 PCR Cartridge.

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