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Dialisa 2mp

FDA UDI

Class I (US FDA UDI)

by Dynex Technologies, Inc.

Identity

Trade Name
DIALISA 2MP FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Device Name
DIALISA 2MP, DS2 Automated ELISA Processing System FDA UDI
Model / Reference
62003 FDA UDI
Description
DIALISA 2MP, DS2 Automated ELISA Processing System FDA UDI

Identifiers

Catalog Number
62003 FDA UDI
Primary DI / UDI-DI
05060456180348 FDA UDI
FDA Product Code
LXG FDA UDI
JJQ FDA UDI
JQW FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 FDA UDI
862.2300 FDA UDI
862.2750 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple clinical chemistry analyser IVD, laboratory

Dialisa 2mp by Dynex Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, laboratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dynex Technologies, Inc.

Sources (1)

  • FDA UDI 3d604ef7-9895-435f-b23b-8c624ffdb449 36 fields · synced Jun 6, 2026