Neonatal G6PD

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

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• 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

Primary placement in Finland; available across 1 country total.

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

Trade name

Neonatal G6PD

UDI-DI code

06438172192010

Basic UDI-DI

B-06438172192010

Reference / catalog number

6199860

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

Labsystems Diagnostics’ Neonatal G6PD test is designed for the quantitative in vitro determination of glucose-6-phosphate dehydrogenase activity in blood samples dried on filter paper intended for newborn screening of glucose-6-phosphate dehydrogenase deficiency.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010199ENZYMES - OTHER

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