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

805090 — IVDR Class A IVDR by Bio-Rad Medical…

MD Atlas
Bio-Rad Medical Diagnostics GmbH

EUDAMED last updated this device on Dec 19, 2022

805090

361052A002988Q

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Bio-Rad Medical Diagnostics GmbH
UDI-DI code: 07611969950829
Reference / catalog number: 805090

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: Bio-Rad Medical Diagnostics GmbH
SRN: DE-MF-000019864
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 Germany; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 07611969950829
Basic UDI-DI: 361052A002988Q
Reference / catalog number: 805090
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: 10
Additional product description: Rinderalbumin 30% is a bovine albumin solution intended to be used as an enhancement for human red blood cell antibody/antigen reactions in the tube method as part of immunohematology testing. For in vitro diagnostic use, by trained laboratory personnel.
Additional information URL: https://downloads.bio-rad.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103030306ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)

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

Related devices

806505361052A002918AOn the market 806506361052A002918AOn the market 12014332361052A002928COn the market 805200361052A002928COn the market 805205361052A002928COn 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.