Identity
- Trade Name
- AmplideX Fragile X Dx & Carrier Screen Kit FDA UDI
- Generic Name
- Fragile X syndrome IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- 49591 FDA UDI
Identifiers
- Catalog Number
- 49591 FDA UDI
- Primary DI / UDI-DI
- 00863840000254 FDA UDI
- 510(k) Number
- DEN190023 FDA UDI
- FDA Product Code
- OYV FDA UDI
- GMDN Term
- Fragile X syndrome IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5970 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fragile X syndrome IVD, kit, nucleic acid technique (NAT)
AmplideX Fragile X Dx & Carrier Screen Kit by Asuragen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Asuragen, Inc.
Sources (1)
- FDA UDI 04a6fb18-5ac0-4b00-bdd8-770addffa1dd 35 fields · synced May 30, 2026