PTH Quantitative Test Kit (Time-Resolved FIA)

Trade name

PTH Quantitative Test Kit (Time-Resolved FIA)

UDI-DI code

D-FKPTH-402aDL

Basic UDI-DI

B-FKPTH-402aDL

Reference / catalog number

FKPTH-402a

Issuing entity

EUDAMED

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

The PTH Quantitative Test Kit (Time-Resolved FIA) is a rapid fluorescence immunoassay for in vitro quantitative detection of the concentration of Parathyroid hormone (PTH) in human serum, plasma and whole blood. Mainly used for the differential diagnosis of hypercalcemia and hypocalcemia. For in vitro diagnostic use. For professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102060312PARATHYROID HORMONE INTACT

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

• CW009

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.