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Anti-Streptolysin O Standard (aso Std)

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
ANTI-STREPTOLYSIN O STANDARD (ASO STD) FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator FDA UDI
Model / Reference
LO2306 FDA UDI

Identifiers

Primary DI / UDI-DI
05055273204285 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Anti-Streptolysin O Standard (aso Std) by Randox Laboratories, Ltd. — Class II — 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
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 92a53bca-e904-4d59-babc-a8e46454d483 32 fields · synced May 30, 2026