Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

ELSA2-AFP — IVDD — General IVDD by Cisbio Bioassays

MD Atlas
Cisbio Bioassays

EUDAMED last updated this device on May 19, 2022

ELSA2-AFP

B-03770024321098

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cisbio Bioassays
UDI-DI code: 03770024321098
Reference / catalog number: ELSA2-AFP

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

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: 03770024321098
Basic UDI-DI: B-03770024321098
Reference / catalog number: ELSA2-AFP
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: ELSA2-AFP est une trousse destinée au dosage immunoradiométrique de l’alpha-foetoprotéine humaine dans le sérum, le plasma ou le liquide amniotique. La trousse est destinée à un usage professionne
Additional information URL: https://www.cisbio.com/ivd-pi
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102039001ALPHAFETOPROTEIN

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification