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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Gentamicin therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
ARCHITECT iGentamicin Calibrators FDA UDI
Model / Reference
1P31-01 FDA UDI
Description
ARCHITECT iGentamicin Calibrators FDA UDI

Identifiers

Catalog Number
01P3101 FDA UDI
Primary DI / UDI-DI
00380740001735 FDA UDI
510(k) Number
K102699 FDA UDI
FDA Product Code
LCD FDA UDI
DLJ FDA UDI
GMDN Term
Gentamicin therapeutic drug monitoring IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3450 FDA UDI
862.3200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Gentamicin therapeutic drug monitoring IVD, calibrator

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

Similar devices

Also classified as Gentamicin therapeutic drug monitoring IVD, calibrator.

Cleared under the same submission

K102699 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI f3ab15bd-b436-45c0-999e-53451589c172 37 fields · synced Jun 1, 2026