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Capillarys Hemoglobin

FDA UDI

Class II (US FDA UDI)

by Sebia, Inc.

Identity

Trade Name
CAPILLARYS HEMOGLOBIN FDA UDI
Generic Name
Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
Device Name
Device that detects and measure hemoglobin variants using capillary electrophoresis FDA UDI
Model / Reference
2007 FDA UDI
Description
Device that detects and measure hemoglobin variants using capillary electrophoresis FDA UDI

Identifiers

Catalog Number
2007 FDA UDI
Primary DI / UDI-DI
03607360020074 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple haemoglobin subtype IVD, kit, electrophoresis

Capillarys Hemoglobin 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sebia, Inc.

Sources (1)

  • FDA UDI 3930d8a4-c7fc-411c-b876-99b818e8d9b6 35 fields · synced Jun 1, 2026