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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 PLUS — IVDD — Annex II List B IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Jul 23, 2024

NEOMASS AAAC PLUS

B-06438172403017

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: 06438172403017
Reference / catalog number: 7100110

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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

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

CW096
May damage fertility of unborn child
CW099
Causes damage to organs
CW266
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, HBV, 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.
CW095
Suspected of causing cancer
CW083
May cause an allergic skin reaction
CW085
Causes serious eye irritation.
CW090
May cause respiratory irritation
CW076
Flammable liquid and vapour
CW057
Highly flammable liquid and vapour
CW058
Flammable liquid and vapour
CW075
Toxic if swallowed, in contact with skin or if inhaled.
CW082
Causes skin irritation.

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
UDI-DI code: 06438172403017
Basic UDI-DI: B-06438172403017
Reference / catalog number: 7100110
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 CAH kit is intended for the determination of Androstenedione (ANDRO), Cortisol (CORT), 11-Deoxycortisol (11-DOC), 21-Deoxycortisol (21-DOC), 17-Hydroxyprogesterone (17-OHP) & 21-Hydroxyprogesterone (21-OHP) from whole blood dried on filter paper as a second tier test for detection of Congenital Adrenal Hyperplasia (CAH) in newborns.
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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Software identification