Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Progesterone IVD, control FDA UDI
Device Name: ARCHITECT Progesterone Controls FDA UDI
Model / Reference: 7K77-10 FDA UDI
Description: ARCHITECT Progesterone Controls FDA UDI

Identifiers

Catalog Number: 07K7710 FDA UDI
Primary DI / UDI-DI: 00380740014896 FDA UDI
FDA Product Code: JIT FDA UDI
JJX FDA UDI
GMDN Term: Progesterone IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Progesterone IVD, control

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

Similar devices

Also classified as Progesterone IVD, control.

Atellica IM PRGE MCM — Siemens Healthcare Diagnostics · Class I
IMMULITE® Systems PRG Calibration Verification Material Progesterone — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
LIAISON® Progesterone II Gen Control Set — Diasorin Inc.
ADVIA Centaur® Immunoassay Systems PRGE MCM — Siemens Healthcare Diagnostics · Class I
VALIDATE — LGC Clinical Diagnostics, Inc. · Class I
IDS-iSYS 17-OH Progesterone Control Set — Immunodiagnostic Systems , Ltd. · Class I
Alinity — ABBOTT IRELAND · 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 Ireland

Sources (1)

FDA UDI 989ffa74-a307-4dbc-9210-691724edc79a 36 fields · synced May 30, 2026