Identity
- Trade Name
- CAPILLARYS CDT FDA UDI
- Generic Name
- Transferrin/transferrin isoform IVD, kit, electrophoresis FDA UDI
- Device Name
- CARBOHYDRATE DEF TRANSFERRING BY CE FDA UDI
- Model / Reference
- 2009 FDA UDI
- Description
- CARBOHYDRATE DEF TRANSFERRING BY CE FDA UDI
Identifiers
- Catalog Number
- 2009 FDA UDI
- Primary DI / UDI-DI
- 03607360020098 FDA UDI
- FDA Product Code
- NAO FDA UDI
- GMDN Term
- Transferrin/transferrin isoform IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transferrin/transferrin isoform IVD, kit, electrophoresis
Capillarys Cdt by Sebia, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transferrin/transferrin isoform IVD, kit, electrophoresis.
- CAPILLARYS CDT MAXI KIT — Sebia, Inc. · Class I
- CAPI 3 CDT — Sebia, Inc. · Class I
- MINICAP CDT — Sebia, Inc.
- MINICAP CDT MAXI KIT — Sebia, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sebia, Inc.
Sources (1)
- FDA UDI 9cc4f7a6-e331-49e4-a525-ef0b39bd8ae1 35 fields · synced May 30, 2026