Identity
- Trade Name
- MINICAP HEMOGLOBIN FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
- Device Name
- Device used to measure hemoglobin variants FDA UDI
- Model / Reference
- 2207 FDA UDI
- Description
- Device used to measure hemoglobin variants FDA UDI
Identifiers
- Catalog Number
- 2207 FDA UDI
- Primary DI / UDI-DI
- 03607360022078 FDA UDI
- 510(k) Number
- K082227 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
Minicap Hemoglobin by Sebia, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple haemoglobin subtype IVD, kit, electrophoresis.
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- CAPILLARYS HEMOGLOBIN — Sebia, Inc. · Class II
- CAPI 3 NEONAT HEMOLYSING SOLUTION — Sebia, Inc. · Class II
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 a91dab6d-3323-4b5b-b3ba-09f910f4bdec 36 fields · synced Jun 1, 2026