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

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Organization name
UDI-DI code
Reference / catalog number

NeoMass AAAC 3.0 — IVDD — Annex II List B IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Aug 14, 2024

NeoMass AAAC 3.0

B-06438172402010

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06438172402010
Reference / catalog number: NeoMass AAAC 3.0

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Manufacturer information

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

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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

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

CW008
All human materials used in the preparation of the calibrators/controls in the kit have been tested for the presence of the antibodies to HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) as well as Hepatitis B surface antigen (HBsAg) and found to be non-reactive. Because no test method can offer complete assurance that HIV, hepatitis B virus, HCV, or other infectious agents are absent, these calibrators and controls as well as samples should be handled at the Biosafety level 2 as recommended for any potentially infectious human serum or blood sample in the Centers for Disease Control and prevention/National Institutes for Health Manual, “Biosafety in Microbiological and Biomedical Laboratories,” 5th Ed. 2009
CW057
Highly flammable liquid and vapo
CW076
Harmful if swallowed, in contact with skin or if inhaled
CW075
Toxic if swallowed, in contact with skin or if inhaled
CW082
Causes skin irritation
CW083
May cause an allergic skin reaction
CW085
Causes serious eye irritation
CW090
May cause respiratory irritation
CW099
Causes damage to organs
CW139
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking
CW158
Do not breath dust/fume/gas/mist/vapours /spray
CW159
Avoid breathing dust/ fumes/ gas/ mist/ vapours/ spray
CW162
Wash hands thoroughly after handling
CW164
Use only outdoors or in a well-ventilated area
CW165
Contaminated work clothing should not be allowed out of the workplace

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 3.0
UDI-DI code: 06438172402010
Basic UDI-DI: B-06438172402010
Reference / catalog number: NeoMass AAAC 3.0
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: This NeoMass AAAC 3.0 kit is for the quantitative measurement of amino acids, free carnitine, acylcarnitines, argininosuccinic acid, succinylacetone, lysophospholipid and nucleoside in blood samples dried on filter paper as a primary test for screening of newborns for inborn errors of metabolism.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01010402MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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