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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

SIT EnTy Kit Quick Identification… — IVDR Class A IVDR

MD Atlas
Zakład Badawczo-Wdrożeniowy Ośrodka Salmonella "IMMUNOLAB" Sp. z o. o.

EUDAMED last updated this device on Jul 26, 2024

SIT EnTy Kit Quick Identification Test for in vitro diagnostic of Salmonella Enteritidis and Typhimurium strains

590575374PS004F6

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Zakład Badawczo-Wdrożeniowy Ośrodka Salmonella "IMMUNOLAB" Sp. z o. o.
UDI-DI code: 05905753743783
Reference / catalog number: PS004

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View device family (Basic UDI)

Manufacturer information

Organization name: Zakład Badawczo-Wdrożeniowy Ośrodka Salmonella "IMMUNOLAB" Sp. z o. o.
SRN: PL-MF-000042563
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW267
Rabbit antisera contain material of animal origin and should be handled as potentially infectious.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: SIT EnTy Kit Quick Identification Test for in vitro diagnostic of Salmonella Enteritidis and Typhimurium strains
UDI-DI code: 05905753743783
Basic UDI-DI: 590575374PS004F6
Reference / catalog number: PS004
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The SIT EnTy antiserum kit is a medical device for in vitro diagnostics used for the quick identification of Salmonella Enteritidis and Typhimurium strains isolated from samples taken from humans, animals or other research material.
Additional information URL: https://chrome-extension//efaidnbmnnnibpcajpcglclefindmkaj/https://immunolab.com.pl/wp-content/uploads/2024/05/IU_S_2-Instrukcja-uzywania-zestaw-surowic-SIT-EnTy.docx-.pdf
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05905753743783

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

W0104080301SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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