Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Buffered wash solution IVD FDA UDI
Device Name: Alkaline Wash FDA UDI
Model / Reference: 9D31-20 FDA UDI
Description: Alkaline Wash FDA UDI

Identifiers

Catalog Number: 09D3120 FDA UDI
Primary DI / UDI-DI: 00380740019341 FDA UDI
FDA Product Code: CGZ FDA UDI
JJE FDA UDI
CEM FDA UDI
JGS FDA UDI
GMDN Term: Buffered wash solution IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1170 FDA UDI
862.2160 FDA UDI
862.1600 FDA UDI
862.1665 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Buffered wash solution IVD

Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Buffered wash solution IVD.

ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I
ADVIA Centaur® PW3 — Siemens Healthcare Diagnostics · Class I
VENTANA HE 600 Wash — Ventana Medical Systems · Class I
TBS Auto Wash Buffer 20X — BIOCARE MEDICAL, LLC · Class I
ADVIA Centaur® PW 4 — Siemens Healthcare Diagnostics · Class I
COBAS® AMPLICOR Wash Buffer — Roche Molecular Systems, Inc.
ISE Buffer Reagent — DIAMOND DIAGNOSTICS Inc
ADVIA Centaur® Wash 1 — Siemens Healthcare Diagnostics · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Abbott Laboratories, Inc.

Sources (1)

FDA UDI 69eb3687-0e52-45ca-a869-c8d03de1ba13 36 fields · synced May 31, 2026