← Back to catalogue

AccuDiag ™

FDA UDI

Class I (US FDA UDI)

by Diagnostic Automation, Inc.

Identity

Trade Name
AccuDiag ™ FDA UDI
Generic Name
Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
Model / Reference
DACD8209-35 FDA UDI
Description
AccuDiag™ Schistosoma IgG ELISA - For the qualitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI

Identifiers

Catalog Number
8209-35 FDA UDI
Primary DI / UDI-DI
00894175000114 FDA UDI
FDA Product Code
GNH FDA UDI
GMDN Term
Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3600 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: Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Diagnostic Automation, Inc.

Sources (1)

  • FDA UDI 38955e07-67a7-4240-ab68-f4a7ef365991 37 fields · synced Jun 1, 2026