Neonatal Phenylalanine

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

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

• CW266

  Each donor unit used in the preparation of the kit calibrators and controls has been tested for the presence of the antibodies to HIV (human immunodeficiency virus) and HCV as well as for hepatitis B markers and found to be negative. Because no test method can offer complete assurance that HIV, HCV, hepatitis B virus, or other infectious agents are absent, these calibrators, controls as well as specimens should be handled at the Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the Centers for Disease Control/National Institutes of Health manual “Biosafety in Microbiological and Biomedical Laboratories”, 2009. In addition, handle and dispose of the Microstrips® as well as all material coming into contact with them or with the specimens, calibrators and controls as if capable of transmitting infection. Discard solutions into a waste drainage network and flush with large volumes of water.
• 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 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 wastes 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 Phenylalanine

UDI-DI code

06438172085015

Basic UDI-DI

B-06438172085015

Reference / catalog number

6199896

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

The kit is designed for the quantitative in vitro determination of phenylalanine concentration in blood specimens dried on filter paper intended for newborn screening for phenylketonuria (PKU).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010236PHENYLKETONURIA

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