C-Pep Ii-Ria-Ct

FDA UDI

Class I (US FDA UDI)

by Diasource Immunoassays, S.A.

Identity

Trade Name: C-PEP II-RIA-CT FDA UDI
Generic Name: C-peptide IVD, kit, radioimmunoassay FDA UDI
Device Name: C-PEP II-RIA-CT FDA UDI
Model / Reference: KIP0409 FDA UDI
Description: C-PEP II-RIA-CT FDA UDI

Identifiers

Primary DI / UDI-DI: 05400569000322 FDA UDI
FDA Product Code: JKD FDA UDI
GMDN Term: C-peptide IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1135 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: C-peptide IVD, kit, radioimmunoassay

C-Pep Ii-Ria-Ct by Diasource Immunoassays, S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Diasource Immunoassays, S.A.

Sources (1)

FDA UDI 65aa49d8-dc25-413b-aea7-b24f4a9053ce 33 fields · synced Jun 8, 2026