YC500012

Organization name

Technogenetics S.p.A

SRN

IT-MF-000025331

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW265

  TGS TA Immunocleaner contains 2.4% Sodium Hypochlorite (NaClO) and 0.5% Sodium Hydroxide (NaOH): the solution must be handled using the appropriate personal protective equipment used for handling diagnostics kits, to ensure that it does not come into contact with skin and eyes.
• CW011

  TGS TA Immunocleaner must be used only for in vitro diagnostics and must not be used for in vivo diagnostics in humans or animals

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Trade name

not provided

UDI-DI code

08054320950998

Basic UDI-DI

805432095IMMUNOCLEANERJJ

Reference / catalog number

YC500012

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

TGS TA Immunocleaner is used for daily cleaning and decontamination of the dispenser needle of the TGS TA Analyser 120 or IDS-iSYS Multi-Discipline Automated System instrumentation. TGS TA Immunocleaner is used in combination with the reagents in the IDS-iSYS Cartridge Checking System (CCS) kit to make the instrument suitable for performing dosages. TGS TA Immunocleaner can be used in combination with reagents from any batch. This product must be used in strict compliance with the instructions given in this document by professional users.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01029099IMMUNOCHEMISTRY REAGENTS - OTHER