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Organization name
UDI-DI code
Reference / catalog number

GastroFinder® 2SMART — IVDR Class B IVDR by PathoFinder B.V.

MD Atlas
PathoFinder B.V.

EUDAMED last updated this device on Feb 21, 2023

GastroFinder® 2SMART

87193271161PF5600-2SVQ

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: PathoFinder B.V.
UDI-DI code: 08719327116104
Reference / catalog number: PF5600-2S

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Manufacturer information

Organization name: PathoFinder B.V.
SRN: NL-MF-000002704
Manufacturer status: Active

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Sep 23, 2022	Still on market

Device identification

Trade name: GastroFinder® 2SMART
UDI-DI code: 08719327116104
Basic UDI-DI: 87193271161PF5600-2SVQ
Reference / catalog number: PF5600-2S
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Intended Purpose: The GastroFinder® 2SMART (Single tube Multiplex Amplification in Real Time) Kit is a non-automated qualitative multiplex PCR-based test to aid in diagnosis of gastroenteritis in humans by detecting and differentiating 9 species/groups of bacteria, 4 parasites and 5 viruses: Campylobacter spp. (C. jejuni, C. coli, C. lari and C. upsaliensis only, not differentiated), Salmonella spp. (S. enterica and S. bongori only, not differentiated), Yersinia enterolitica, Clostridium difficile toxin A, Clostridium difficile toxin B, Shiga toxin producing E. coli (STEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC), Shigella / Enteroinvasive E. coli (EIEC) (not differentiated), Entamoeba histolytica, Giardia lamblia, Cryptosporidium spp. (C. parvum, C. hominis C. meleagridis, C. felis and C. canis only, not differentiated), Dientamoeba fragilis, Norovirus (types GI, GII and GIV (not differentiated)), Rotavirus (type A), Adenovirus (types 40 and 41(not differentiated)), Astrovirus and Sapovirus (types GI, GII, GIV and GV (not differentiated)). The GastroFinder® 2SMART® is for use with LightCycler® 480 / cobas® z480 (Roche), Rotor-Gene® Q / Rotor-Gene® Q MDx (QIAGEN) and QuantStudio™ 5 (Thermo Fisher Scientific). Intended user: The product is for use by trained laboratory professionals only. Other laboratory testing and assessment of clinical presentation must be included in the final diagnosis.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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Software identification

EMDN nomenclature code(s)

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

W0105050208GIARDIA LAMBLIA
W0105050201ENTAMOEBA HISTOLYTICA
W0105011606YERSINIA - NA REAGENTS
W0105011099SALMONELLA REAGENTS - OTHER
W0105011499CAMPYLOBACTER REAGENTS - OTHER
W0105011899C.DIFFICILE REAGENTS - OTHER
W0105040530ASTROVIRUS - NA REAGENTS
W0105040516NOROVIRUS - NA REAGENTS
W0105040506ROTAVIRUS - NA REAGENTS
W0105040501ADENOVIRUS - NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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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.