Devices (same UDI-DI)
1
Certificates
2
Countries
1
Notified Bodies
2
Basic Information
- Primary DI
- 03770029504021
- Basic UDI-DI Code
- B-03770029504021
- Reference
- GNPY #010-011
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- GENOTROPY
Additional Description
The AIO-RHD fetal DNA Kit is a mix of primers specifically design to amplify the exons 5, 7 and 10 of the RHD gene in a specific way without parasitic amplification of the RHCE gene in order to determine the rhesus status of the fetus when the mother status is RHD negative with the complete deletion of the RHD gene. In addition to the RHD specific primers, one extra couple of primer is added to amplify a gene located in 3p25 to be used as amplification control.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103030201 | RHESUS D |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE726461 | BSI Group The Netherlands B.V. | Expired |
| IVDD Annex IV Section 4 | CE726465 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
🇫🇷 France
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).
Multiple Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market