AQUIOS STEM kit

Organization name

IMMUNOTECH SAS

SRN

FR-MF-000011121

Manufacturer status

Active

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

• CW082

  EUDAMED did not publish a description for this code.
• CW083

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW093

  EUDAMED did not publish a description for this code.
• CW094

  EUDAMED did not publish a description for this code.
• CW008

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 32 countries total.

Trade name

AQUIOS STEM kit

UDI-DI code

15099590764425

Basic UDI-DI

150995903B77691UC

Reference / catalog number

B77691

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

AQUIOS STEM Kit is an in vitro diagnostic medical device intended to be used by laboratory professionals for the simultaneous identification and enumeration of percent (%) CD34+ cell population, CD34+ cells/μL, and CD45+ cells/μL in fresh peripheral or mobilized peripheral whole blood, fresh or thawed bone marrow, fresh or thawed apheresis products, and fresh or thawed cord blood on the automated AQUIOS CL Flow Cytometry System.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01030803STEM CELL ENUMERATION REAGENTS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification