Neonatal Biotinidase

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

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• CW263

  BIOLOGICAL RISKS. CONTAINS HUMAN BLOOD OR PLASMA DERIVATIVES. 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,” 6th Ed. 2020. Discard all materials and samples as if capable of transmitting infection. The preferred method of disposal is autoclaving for a minimum of one hour at +121°C. Liquid waste not containing acid and neutralized waste may be mixed with sodium hypochlorite in volumes such that the final mixture contains 50-500 mg/l free available chlorine. Allow 30 minutes for decontamination to be completed. Spills should be wiped off thoroughly using either an iodophor disinfectant or sodium hypochlorite solution. Materials used to wipe off spills should be added to biohazardous waste matter for proper disposal. Reusable glassware must be disinfected, washed out and rinsed free of detergents.

Primary placement in Finland; available across 1 country total.

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

Trade name

Neonatal Biotinidase

UDI-DI code

06438172218017

Basic UDI-DI

B-06438172218017

Reference / catalog number

6199821

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

Neonatal Biotinidase kit is for enzymatic determination of human biotinidase enzyme activity from blood samples dried on filter paper. Intended for newborn screening of biotinidase deficiency. For professional laboratory use only. Both manual use and NS2400 automate use.

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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