Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06954414798920
- Basic UDI-DI Code
- B-06954414798920
- Reference
- /
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Getein Biotech, Inc.
Additional Description
MAGICL PAPP-A (CLIA) is intended for the in vitro quantitative determination of pregnancy-associated plasma protein A (PAPP-A) in human serum. Clinically, this assay is intended for the use as one component in combination with other parameters to evaluate the risk of trisomy 21 (Down syndrome) during the first trimester of pregnancy. For professional use only.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102050210 | PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS) |
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