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DG Reader Net

FDA UDIEUDAMED

Class II (US FDA UDI)

by Diagnostic Grifols Sa

Identity

Trade Name
DG Reader Net FDA UDI
Generic Name
Agglutination assay digital imaging reader/analyser IVD FDA UDI
Device Name
DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes. As a stand-alone or interfaced to the customer’s Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing. FDA UDI
Model / Reference
210700 FDA UDI
Description
DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes. As a stand-alone or interfaced to the customer’s Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing. FDA UDI

Identifiers

Catalog Number
210700 FDA UDI
Primary DI / UDI-DI
08437014205619 FDA UDI
FDA Product Code
KSZ FDA UDI
GMDN Term
Agglutination assay digital imaging reader/analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9175 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Agglutination assay digital imaging reader/analyser IVD

DG Reader Net by Diagnostic Grifols Sa — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Agglutination assay digital imaging reader/analyser IVD.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Grifols Sa

Sources (2)

  • FDA UDI d4820fcf-bc6b-4e9e-9933-321b7cda6d13 34 fields · synced Jun 17, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026