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AccuDiag ™

FDA UDI

Class II (US FDA UDI)

by Diagnostic Automation, Inc.

Identity

Trade Name
AccuDiag ™ FDA UDI
Generic Name
Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
DACD-2553-1 FDA UDI
Description
AccuDiag ™ dsDNA Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Identifiers

Catalog Number
2553-1 FDA UDI
Primary DI / UDI-DI
00894175000237 FDA UDI
FDA Product Code
LSW FDA UDI
GMDN Term
Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Category: Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA)

AccuDiag ™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Native DNA antibody (anti-nDNA) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Automation, Inc.

Sources (1)

  • FDA UDI bd5f335b-9cd6-416c-86bc-5d6ebb5c3204 36 fields · synced Jun 8, 2026