Architect

FDA UDI

Class I (US FDA UDI)

by Abbott

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Total testosterone IVD, calibrator FDA UDI
Device Name: ARCHITECT 2nd Generation Testosterone Calibrators FDA UDI
Model / Reference: 2P13-01 FDA UDI
Description: ARCHITECT 2nd Generation Testosterone Calibrators FDA UDI

Identifiers

Catalog Number: 02P1301 FDA UDI
Primary DI / UDI-DI: 00380740003708 FDA UDI
FDA Product Code: JJX FDA UDI
JIT FDA UDI
CDZ FDA UDI
GMDN Term: Total testosterone IVD, calibrator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1150 FDA UDI
862.1680 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: Total testosterone IVD, calibrator

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

Similar devices

Also classified as Total testosterone IVD, calibrator.

Lumipulse G Testosterone Calibrators — FUJIREBIO INC. · Class II
Dimension Vista® Testosterone Calibrator — Siemens Healthcare Diagnostics · Class II
Calibrator Kit - Testosterone — QUALIGEN INC. · Class II
Alinity — Abbott · Class II

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

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Manufacturer

Manufacturer: Abbott

Sources (1)

FDA UDI 2fc5e63d-bf2b-4419-a097-97b0318f550c 36 fields · synced Jun 8, 2026