Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-6430030990554U9
- Basic UDI-DI Code
- B-6430030990554U9
- Reference
- 30831RETAC
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Actim Oy
Additional Description
10 test kit. The Actim® PROM 1ngeni test is a qualitative immunochromatographic dipstick test for the detection of amniotic fluid in vaginal secretions during pregnancy. Actim PROM 1ngeni detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the amniotic fluid in a vaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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