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

NeoMass AAAC Plus Internal… — IVDD — General IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Jul 23, 2024

NeoMass AAAC Plus Internal standard - Labelled Acylcarnitines (ISTD - AC)

B-06438172403048

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06438172403048
Reference / catalog number: 710011005

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: Labsystems Diagnostics Oy
SRN: FI-MF-000018281
Manufacturer status: Active

Related devices

Biocard Chlamydia pneumoniae IgMB-06416842034013On the market Biocard Helicobacter pylori IgGB-06416842818019On the market 3-035-000B-06416842035010On the market 3-028-200B-06416842928015On the market Biocard™ H pylori IgG HomeB-06416842918030On 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

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

CW082
Causes skin irritation
CW085
Causes serious eye irritation
CW083
May cause an allergic skin reaction

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: NeoMass AAAC Plus Internal standard - Labelled Acylcarnitines (ISTD - AC)
UDI-DI code: 06438172403048
Basic UDI-DI: B-06438172403048
Reference / catalog number: 710011005
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: NeoMass AAAC Plus Internal Standard - Labelled Acylcartinies serves as a comparative standard for the unknown analytes. it is also a component of Neomass AAAC plus kit for newborn screening
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101050301CALIBRATORS MULTICOMPONENT (CC)

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