Research and Diagnostic Systems

FDA UDI

Class II (US FDA UDI)

by Research And Diagnostic Systems, Inc.

Identity

Trade Name: Research and Diagnostic Systems FDA UDI
Generic Name: Erythropoietin (EPO) IVD, control FDA UDI
Device Name: Quantikine Erythropoietin Control 3 (10 vials) FDA UDI
Model / Reference: CEP03 FDA UDI
Description: Quantikine Erythropoietin Control 3 (10 vials) FDA UDI

Identifiers

Catalog Number: CEP03 FDA UDI
Primary DI / UDI-DI: 10815762021685 FDA UDI
510(k) Number: K931756 FDA UDI
FDA Product Code: GGT FDA UDI
GMDN Term: Erythropoietin (EPO) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Erythropoietin (EPO) IVD, control

Research and Diagnostic Systems by Research And Diagnostic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Erythropoietin (EPO) IVD, control.

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ADVIA Centaur EPO MCM — Siemens Healthcare Diagnostics · Class I
Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II

Cleared under the same submission

K931756 also covers:

Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.

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: Research And Diagnostic Systems, Inc.

Sources (1)

FDA UDI 3c63a503-685e-4ded-99cf-24eea1d538c6 37 fields · synced May 31, 2026