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AccuDiag ™

FDA UDI

Class II (US FDA UDI)

by Diagnostic Automation, Inc.

Identity

Trade Name
AccuDiag ™ FDA UDI
Generic Name
Free thyroxine (FT4) IVD, kit, radioimmunoassay FDA UDI
Device Name
AccuDiag ™Free T4 ELISA kit is intended for the quantitative Determination of Free Thyroxine Concentration in Human Serum by a Microplate Enzyme Immunoassay. FDA UDI
Model / Reference
DACD3146-15 FDA UDI
Description
AccuDiag ™Free T4 ELISA kit is intended for the quantitative Determination of Free Thyroxine Concentration in Human Serum by a Microplate Enzyme Immunoassay. FDA UDI

Identifiers

Catalog Number
3146-15 FDA UDI
Primary DI / UDI-DI
00894175000923 FDA UDI
FDA Product Code
CEC FDA UDI
GMDN Term
Free thyroxine (FT4) IVD, kit, radioimmunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1695 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: Free thyroxine (FT4) IVD, kit, radioimmunoassay

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

Similar devices

Also classified as Free thyroxine (FT4) IVD, kit, radioimmunoassay.

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 35ca5f7b-9469-4e74-a96f-4f110c0cf95e 37 fields · synced May 29, 2026