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Capi 3 Immunotyping

FDA UDI

Class I (US FDA UDI)

by Sebia, Inc.

Identity

Trade Name
CAPI 3 IMMUNOTYPING FDA UDI
Generic Name
Multiple clinical chemistry protein IVD, reagent FDA UDI
Device Name
Device designed for the qualitative detection and the characterization of monoclonal proteins by capillary electrophoresis FDA UDI
Model / Reference
2600 FDA UDI
Description
Device designed for the qualitative detection and the characterization of monoclonal proteins by capillary electrophoresis FDA UDI

Identifiers

Catalog Number
2600 FDA UDI
Primary DI / UDI-DI
03607360026007 FDA UDI
510(k) Number
K161928 FDA UDI
FDA Product Code
JJY FDA UDI
DFH FDA UDI
DEH FDA UDI
CEF FDA UDI
CFF FDA UDI
GMDN Term
Multiple clinical chemistry protein IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
866.5550 FDA UDI
862.1630 FDA UDI
866.5510 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 clinical chemistry protein IVD, reagent

Capi 3 Immunotyping by Sebia, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry protein IVD, reagent.

Cleared under the same submission

K161928 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sebia, Inc.

Sources (1)

  • FDA UDI 859e33e9-3132-432e-8238-2a042764833f 36 fields · synced May 30, 2026