Architect

FDA UDI

Class I (US FDA UDI)

by Abbott

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Insulin IVD, control FDA UDI
Device Name: ARCHITECT Insulin Controls FDA UDI
Model / Reference: 08K4112 FDA UDI
Description: ARCHITECT Insulin Controls FDA UDI

Identifiers

Catalog Number: 08K4112 FDA UDI
Primary DI / UDI-DI: 00380740169817 FDA UDI
FDA Product Code: JJX FDA UDI
GMDN Term: Insulin IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Insulin IVD, control

Architect by Abbott — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Insulin IVD, control.

Insulin control slides — BIO SB, INC. · Class I
K-ASSAY® Insulin Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
IMMULITE® Systems INS Calibration Verification Material Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Insulin control slides — BIO SB, INC. · Class I
IMMULITE® INS Control Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Diazyme — Diazyme Laboratories, Inc.
Audit MicroControls Linearity FD Special Diabetes for Ortho Vitros — Aalto Scientific, Ltd.
Atellica IM IRI MCM — 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 I	Pending data

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

Manufacturer

Manufacturer: Abbott

Sources (1)

FDA UDI d0a207e1-eea5-4d01-8472-c49060f78c1d 36 fields · synced May 30, 2026