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Sign in to claim this brandAsuragen, Inc.
United States·US-MF-000011830
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 2150, Woodward St., Austin, United States
- Website
- asuragen.com/emea/
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Stephanie Mantooth
- EUDAMED SRN
- US-MF-000011830
- FDA FEI Number
- 3003436513
- DUNS Number
- 622988330
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AmplideX SMA Plus Kit (100 rxn) | A00056 | EUDAMED | IVD General | Active |
| QuantideX qPCR BCR-ABL minor Kit | 49640 | EUDAMED | IVD General | Active |
| AmplideX SMA Plus Kit (50 rxn) | A00055 | EUDAMED | IVD General | Active |
| AmplideX mPCR FMR1 Test | A00401 | EUDAMED | IVD General | Active |
| AmplideX DM1 Dx Kit | 76048 | EUDAMED | IVD General | Active |
| ROX 1000 Size Ladder | A00058 | FDA UDI | Class I | Active |
| RNARetain | 84001 | FDA UDI | Class II | Active |
| QuantideX qPCR BCR-ABL IS Kit | 49574 | FDA UDI | Class II | Active |
| AmplideX Fragile X Dx & Carrier Screen Kit | 49591 | FDA UDI | Class II | Active |
| Quantidex qPCR BCR-ABL IS Kit | DEN160003 | FDA 510(k) | Class II | Active |
| AmplideX Fragile X Dx & Carrier Screen Kit | DEN190023 | EUDAMEDFDA 510(k) | Class II | Active |
| Rnaretain | K113420 | FDA 510(k) | Class II | Active |
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