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AccuDiag™

FDA UDI

Class I (US FDA UDI)

by Diagnostic Automation, Inc.

Identity

Trade Name
AccuDiag™ FDA UDI
Generic Name
Phospholipid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA FDA UDI
Model / Reference
DACD2560-6 FDA UDI
Description
AccuDiag™ Anti-Phospholipid Screen IgG/IgM ELISA FDA UDI

Identifiers

Catalog Number
2560-6 FDA UDI
Primary DI / UDI-DI
00850049545518 FDA UDI
FDA Product Code
JNT FDA UDI
GMDN Term
Phospholipid antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1575 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: Phospholipid 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 Phospholipid antibody 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 a7374bd6-9590-4a09-8b34-16732db6ea8b 37 fields · synced May 30, 2026