06-5001-01

Organization name

MacroArray Diagnostics

SRN

AT-MF-000030541

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW043

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 32 countries total.

Trade name

not provided

UDI-DI code

09120122920657

Basic UDI-DI

91201229206JY

Reference / catalog number

06-5001-01

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

50

Additional product description

The ALEX Air test system is a quantitative in vitro diagnostic test for the measurement of 59 allergen specific IgE (sIgE) of inhalative allergens and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma.

Additional information URL

https://www.madx.com/extras

Clinical sizes

No clinical sizes registered for this device.

• W01020205IMMUNOGLOBULIN E - SCREEN

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

Certificate health across this manufacturer's portfolio.