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K-ASSAY® ASO (WHO) Reagent

FDA UDI

Class I (US FDA UDI)

by Kamiya Biomedical Company, Llc

Identity

Trade Name
K-ASSAY® ASO (WHO) Reagent FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent FDA UDI
Device Name
For the quantitative determination of human streptolysin O (ASO) in serum by immunoturbidimetric assay. FDA UDI
Model / Reference
KAI-078 FDA UDI
Description
For the quantitative determination of human streptolysin O (ASO) in serum by immunoturbidimetric assay. FDA UDI

Identifiers

Catalog Number
KAI-078 FDA UDI
Primary DI / UDI-DI
00816426020337 FDA UDI
FDA Product Code
GTQ FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent 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, reagent

K-ASSAY® ASO (WHO) Reagent by Kamiya Biomedical Company, Llc — 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, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kamiya Biomedical Company, Llc

Sources (1)

  • FDA UDI 4eb4699c-a32b-4b96-ade5-526c374c7c18 36 fields · synced May 30, 2026