Identity
- Trade Name
- CAPI 3 NEONAT HEMOLYSING SOLUTION FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
- Model / Reference
- 2563 FDA UDI
Identifiers
- Catalog Number
- 2563 FDA UDI
- Primary DI / UDI-DI
- 03607360025635 FDA UDI
- 510(k) Number
- K232027 FDA UDI
- FDA Product Code
- GKA FDA UDI
- GMDN Term
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7415 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple haemoglobin subtype IVD, kit, electrophoresis
Capi 3 Neonat Hemolysing Solution by Sebia, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple haemoglobin subtype IVD, kit, electrophoresis.
- CAPILLARYS NEONAT Hb — Sebia, Inc.
- CAPI 3 NEONAT Hb — Sebia, Inc. · Class II
- CAPILLARYS HEMOGLOBIN — Sebia, Inc. · Class II
- MINICAP HEMOGLOBIN — Sebia, Inc. · Class II
Cleared under the same submission
K232027 also covers:
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
- Sebia, Inc.
Sources (1)
- FDA UDI 25d1c6b9-cecc-4d69-bd6c-ce8df1fdddb8 35 fields · synced May 31, 2026