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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

ELSA-FBHCG — IVDD — General IVDD by Cisbio Bioassays

MD Atlas
Cisbio Bioassays

EUDAMED last updated this device on May 19, 2022

ELSA-FBHCG

B-03770024321166

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cisbio Bioassays
UDI-DI code: 03770024321166
Reference / catalog number: ELSA-FBHCG

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Manufacturer information

Organization name: Cisbio Bioassays
SRN: FR-MF-000024051
Manufacturer status: Active

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RENINE III GENERATIONB-03770024321319On the market RG-AFPB-03770024321340On the market RIA-gnost FT3B-03770024321371On the market RIA-gnost FT3B-03770024321364On the market RIA-gnost FT4B-03770024321388On 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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW267
EUDAMED did not publish a description for this code.
CW266
EUDAMED did not publish a description for this code.
CW265
EUDAMED did not publish a description for this code.
CW028
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 03770024321166
Basic UDI-DI: B-03770024321166
Reference / catalog number: ELSA-FBHCG
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: ELSA-FBHCG est une trousse destinée au dosage immunoradiométrique spécifique de la sous-unité  libre de l’hormone chorionique gonadotrope (FHCG) dans le sérum ou le plasma. La trousse est destinée à un usage professionnel
Additional information URL: https://www.cisbio.com/ivd-pi
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102050213FREE BETA HCG (PRENATAL SCREENING)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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