YM1000

Organization name

Immundiagnostik AG

SRN

DE-MF-000020905

Manufacturer status

Active

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Primary placement in Germany; available across 30 countries total.

Trade name

not provided

UDI-DI code

04050598012370

Basic UDI-DI

4050598CMVITV2

Reference / catalog number

YM1000

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

1,25-(OH)2-Vitamin D3/D2 ImmuTube® LC-MS/MS is for the LC-MS/MS based quantification of 1,25-(OH)2-vitamin D3 and 1,25-(OH)2-vitamin D2 in serum and plasma after immunoaffinity enrichment (ImmuTube®). The assay is an in vitro diagnostic medical device for manual use by professional laboratory staff in a laboratory environment. It is used for the determination of the vitamin D metabolite composition in patients with suspected impaired vitamin D metabolism. It can thus be used as a support in the differentiated assessment of the vitamin D status, also in the context of a therapy of vitamin D deficiency by supplementation of vitamin D.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01020603081.25-DIHYDROXYVITAMIN D

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