Neonatal Toxoplasma gondii IgM FEIA

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

2 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
• CW999

  Relevant R-phrases: 34 Causes burns 36/38 Irritating to eyes, respiratory system and skin. 43 May cause sensitization by skin contact. Relevant S-phrases: 24/25 Avoid contact with skin and eyes 37 Wear suitable protective clothes and gloves

Primary placement in Finland; available across 1 country total.

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

Trade name

Neonatal Toxoplasma gondii IgM FEIA

UDI-DI code

06438172116016

Basic UDI-DI

B-06438172116016

Reference / catalog number

6199802

Issuing entity

GS1

Risk category

IVDD — Annex II List B

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

This Neonatal Toxoplasma gondii IgM FEIA kit is intended for the determination of IgM-class antibodies to Toxoplasma gondii in blood samples dried on filter paper. The test is intended as a primary method for screening of newborns for congenital toxoplasmosis (CT). Because IgM-class antibodies due to their high molecular weight do not cross placenta, determination of specific antibodies in newborn samples taken shortly after birth indicates exposure of the fetus intra utero to Toxoplasma gondii. Cases showing elevated levels of specific antibodies should be further investigated.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105050103TOXOPLASMA ANTIBODY IGM

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