Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Device Name: Hemoglobin A1c Controls FDA UDI
Model / Reference: 2K96-10 FDA UDI
Description: Hemoglobin A1c Controls FDA UDI

Identifiers

Catalog Number: 02K9610 FDA UDI
Primary DI / UDI-DI: 00380740003616 FDA UDI
FDA Product Code: LCP FDA UDI
GGM FDA UDI
KRZ FDA UDI
GMDN Term: Glycated haemoglobin (HbA1c) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7470 FDA UDI
864.8625 FDA UDI
864.8165 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: Glycated haemoglobin (HbA1c) IVD, control

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

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Also classified as Glycated haemoglobin (HbA1c) IVD, control.

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Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
HbA1c — POINTE SCIENTIFIC, INC. · Class II
MAS Diabetes Max, Multi-pack — Microgenics Corporation · Class I
MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2) — Sebia, Inc. · Class I
PreciControl HbA1c path — Roche Diagnostics Corp. · Class I
Liquichek — Bio-Rad Laboratories · 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 7bd57787-6a43-4342-8ea2-d20fb692ce98 36 fields · synced May 30, 2026