Neonatal T4 FEIA

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

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

• 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, 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
• CW083

  May cause an allergic skin reaction
• CW081

  Causes severe skin burns and eye damage

Primary placement in Finland; available across 1 country total.

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

Trade name

Neonatal T4 FEIA

UDI-DI code

06438172220010

Basic UDI-DI

B-06438172220010

Reference / catalog number

6199890

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

This Neonatal T4 FEIA kit is for the quantitative measurement of total Thyroxine (T4) concentration in blood samples dried on filter paper as a primary test for screening of babies for congenital hypothyroidism (CH).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01020411NEONATAL THYROXINE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification