abSEQ™ Sequencing Set PE150
Ref 302012
abSEQ™ Sequencing Set PE150 (302012) is a Class A device made by AITbiotech Pte Ltd, registered in EUDAMED on 21 Jul 2026 (Basic UDI-DI 888501971302012U8), active as of 24 Oct 2026.
Active
CE IVDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number888501971302012U8 | Date21 Jul 2026 | StatusActive |
Official records
- EUDAMED public site 888501971302012U8
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device name
- abSEQ™ Sequencing Set PE150
- Model / reference
- 302012
- Primary DI / UDI-DI
- 08885019711244, 08885019711251
- Basic UDI-DI
- 888501971302012U8
- EMDN code
- W0105900103 Supplemental na reagents
- Device class
- Class A
- EU registration type
- Standard device
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- SG-MF-000003510
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
From the manufacturer
Manufacturer's product page: Ab SEQ Detail
Similar devices in this category
Other devices filed under SUPPLEMENTAL NA REAGENTS.
- Alinity m 09N20-001 by Abbott Molecular
- Nucleic Acid Extraction Reagent 201201 by Yaneng BIOscience (Shenzhen) Co., Ltd.
- Alinity m 09N50-001 by Abbott Molecular
- Nucleic Acid Extraction Reagent 200801 by Yaneng BIOscience (Shenzhen) Co., Ltd.
- EasyScreen™ Sample Processing Kit SP012 by Genetic Signatures Limited