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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Treponema pallidum total antibody IVD, calibrator FDA UDI
Device Name
ARCHITECT Syphilis TP Calibrator FDA UDI
Model / Reference
8D06-04 FDA UDI
Description
ARCHITECT Syphilis TP Calibrator FDA UDI

Identifiers

Catalog Number
08D0604 FDA UDI
Primary DI / UDI-DI
00380740103538 FDA UDI
510(k) Number
K153730 FDA UDI
FDA Product Code
JIT FDA UDI
JJX FDA UDI
LIP FDA UDI
GMDN Term
Treponema pallidum total antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
862.1660 FDA UDI
866.3830 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: Treponema pallidum total antibody IVD, calibrator

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

Similar devices

Also classified as Treponema pallidum total antibody IVD, calibrator.

Cleared under the same submission

K153730 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 29921cc5-005d-4b6d-b12b-e2e42db2c6b2 37 fields · synced May 30, 2026