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Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set

FDA UDI

Class I (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set FDA UDI
Generic Name
Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical FDA UDI
Device Name
Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to streptococcal exoenzymes in human serum. FDA UDI
Model / Reference
ASO-100 FDA UDI
Description
Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to streptococcal exoenzymes in human serum. FDA UDI

Identifiers

Catalog Number
ASO-100 FDA UDI
Primary DI / UDI-DI
10673486002447 FDA UDI
FDA Product Code
GTQ FDA UDI
GMDN Term
Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical 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 multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical

Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set by Teco Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI b3f4995e-31d5-4c6a-b6ec-0d880b9e9f39 36 fields · synced Jun 8, 2026