RE53041

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW266

  EUDAMED did not publish a description for this code.
• CW267

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049325030152

Basic UDI-DI

4049325IVR06080004BTQ

Reference / catalog number

RE53041

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Enzyme immunoassay for the quantitative measurement of total 25-OH Vitamin D (25-OH Vitamin D2 and 25-OH Vitamin D3) in human serum as a physiological marker as an aid to the diagnosis of vitamin D sufficiency. Patient population includes individuals who are at risk to deviate from sufficient levels of vitamin D. The 25-OH Vitamin D ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding and measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. The assay is adaptable by laboratory personnel to automate on open ELISA based liquid handler platforms; however, the programming of the steps and timing required by the manual kit assay test instructions must be strictly adhered to and verified by the laboratory. Test results are calculated from a standard curve and compared to defined cut-off. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or lay person use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W010206030925-HYDROXYVITAMIN D

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