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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

Neonatal 17-OH-Progesterone FEIA — IVDD — General IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Aug 13, 2024

Neonatal 17-OH-Progesterone FEIA

B-06438172205031

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: 06438172205031
Reference / catalog number: 6199871

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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

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

CW159
Avoid breathing dust/fume/gas/mist/vapours/spray
CW165
Contaminated work clothing should not be allowed out of the workplace
CW166
Avoid release to the environment
CW167
Wear protective gloves/ protective clothing/ eye protection/ face protection
CW416
If in eyes: rinse cautiously with water for several minutes, remove contact lenses, if present and easy to do, continue rinsing
CW158
Do not breathe dust/fume/gas/mist/vapours/spray
CW444
If on skin (or hair): remove/ take off immediately all contaminated clothing, rinse skin with water/ shower
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
CW081
Causes severe skin burns and eye damage
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: Neonatal 17-OH-Progesterone FEIA
UDI-DI code: 06438172205031
Basic UDI-DI: B-06438172205031
Reference / catalog number: 6199871
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: Labsystems Diagnostics Neonatal 17-OH-Progesterone FEIA test is a simple competition fluorometric enzyme immunoassay enabling the quantification of 17-hydroxyprogestrone steroid present in blood samples dried on filter paper.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W010205010717 OH PROGESTERONE

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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