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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland Diagnostics

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Multiple traumatic brain injury marker IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
GFAP Reagent Kit 100 Tests FDA UDI
Model / Reference
04W1627 FDA UDI
Description
GFAP Reagent Kit 100 Tests FDA UDI

Identifiers

Catalog Number
04W1627 FDA UDI
Primary DI / UDI-DI
00380740213954 FDA UDI
FDA Product Code
QAT FDA UDI
GMDN Term
Multiple traumatic brain injury marker IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5830 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

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 traumatic brain injury marker IVD, kit, chemiluminescent immunoassay

Architect by Abbott Ireland Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple traumatic brain injury marker IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland Diagnostics

Sources (1)

  • FDA UDI 72568b2a-f37f-4151-80ac-ea9b846f2803 36 fields · synced May 30, 2026