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Architect

FDA UDI

Class I (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator FDA UDI
Device Name
Quantia ASO Calibrator FDA UDI
Model / Reference
06K4604 FDA UDI
Description
Quantia ASO Calibrator FDA UDI

Identifiers

Catalog Number
06K4604 FDA UDI
Primary DI / UDI-DI
00380740156305 FDA UDI
FDA Product Code
GTQ FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3720 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator

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

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Laboratories, Inc.

Sources (1)

  • FDA UDI 4c2c2a63-88e5-473e-9118-aa4306adf95b 36 fields · synced May 30, 2026