1,25-(OH)2-Vitamin D3/D2 IDKenhance® IDKmagnetics® DIY

Organization name

Immundiagnostik AG

SRN

DE-MF-000020905

Manufacturer status

Active

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

• CW267

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

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

Trade name

1,25-(OH)2-Vitamin D3/D2 IDKenhance® IDKmagnetics® DIY

UDI-DI code

04050598011168

Basic UDI-DI

B-04050598011168

Reference / catalog number

KM1042

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

1,25-(OH)2-Vitamin D3/D2 IDKenhance® IDKmagnetics® DIY 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 (IDKmagnetics®) and derivatization (IDKenhance®). The assay is an in vitro diagnostic medical device for manual use by professional laboratory staff in a laboratoy 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

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