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Capillarys Immunotyping

FDA UDI

Class I (US FDA UDI)

by Sebia, Inc.

Identity

Trade Name
CAPILLARYS IMMUNOTYPING FDA UDI
Generic Name
Multiple clinical chemistry protein IVD, reagent FDA UDI
Device Name
Device used for the detection and characterization of monoclonal proteins in human serum and urine using capillary electrophoresis FDA UDI
Model / Reference
2100 FDA UDI
Description
Device used for the detection and characterization of monoclonal proteins in human serum and urine using capillary electrophoresis FDA UDI

Identifiers

Catalog Number
2100 FDA UDI
Primary DI / UDI-DI
03607360021002 FDA UDI
FDA Product Code
CEF FDA UDI
DEH FDA UDI
DFH FDA UDI
CFF FDA UDI
GMDN Term
Multiple clinical chemistry protein IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1630 FDA UDI
866.5550 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

Capillarys 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sebia, Inc.

Sources (1)

  • FDA UDI d62c112d-1cdc-49dc-bfc5-6fce331fd7b0 35 fields · synced Jun 8, 2026