Eu Ivdr
Eu Ivd Class B
On The Market
๐ช๐ธ Spain
Promonitor-ADL
Devices (same UDI-DI)
1
Certificates
0
Countries
15
Notified Bodies
0
Basic Information
- Primary DI
- 08437013457477
- Basic UDI-DI Code
- 8437013457Promonitor003GT
- Reference
- 5080230000
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Progenika Biopharma, S.A.
Additional Description
Promonitor-ADL is an enzyme-linked immunosorbent assay (ELISA) for the quantitative detection of adalimumab (ADL) in human serum. Promonitor-ADL test, in conjunction with other clinical and laboratory findings, is useful as an aid in the management of patients treated with ADL, like patients with inflammatory bowel disease (IBD) and rheumatoid arthritis (RA). Promonitor-ADL is for In Vitro Diagnostic Use. The product is intended for professional use in a laboratory environment.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102080702 | ADALIMUMAB |
Available In Countries
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐น Italy
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom
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