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Organization name
UDI-DI code
Reference / catalog number

EntericBio ® CPE — IVDD — General IVDD by Serosep Limited

MD Atlas
Serosep Limited

EUDAMED last updated this device on Jul 8, 2022

EntericBio ® CPE

B-05391513879272

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Serosep Limited
UDI-DI code: 05391513879272
Reference / catalog number: EBCPE

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Manufacturer information

Organization name: Serosep Limited
SRN: IE-MF-000020322
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Ireland; available across 1 country total.

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

Device identification

Trade name: EntericBio ® CPE
UDI-DI code: 05391513879272
Basic UDI-DI: B-05391513879272
Reference / catalog number: EBCPE
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: For in vitro diagnostic use. The EntericBio® CPE assay is a semi-automated, molecular diagnostic test for the direct, qualitative detection of carbapenemase genes in Enterobacteriaceae from human stool specimens. The assay is intended for use with stool samples or rectal swabs (in liquid medium) as well as bacterial isolates cultured from clinical specimens to aid in the detection, identification and infection control of carbapenemase-producing Enterobacteriaceae that colonise patients in healthcare settings. The EntericBio® CPE assay can be used in combination with the optional UgenTec FastFinder software using the EntericBio® CPE plug-in for the analysis and results interpretation of the EntericBio® CPE assay PCR raw data results generated on the Roche LightCycler® 480 II PCR instrument.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0104080606NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
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Software identification

Related devices

EntericBio Gastro Panel 2B-05391513879296On the market EntericBio Workstation0539151387INST2ROn the market EntericBio® C.difficile plug-in0539151387CDIFFPY4On the market EntericBio® Clostridioides difficileB-05391513879166On the market EntericBio® CPE plug-inB-05391513879579On the market

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.