Identity
- Trade Name
- ASI ASO Slide Test FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent FDA UDI
- Device Name
- Detection of Anti-Streptolysin-O, Export FDA UDI
- Model / Reference
- NC-300050E FDA UDI
- Description
- Detection of Anti-Streptolysin-O, Export FDA UDI
Identifiers
- Catalog Number
- NC-300050E FDA UDI
- Primary DI / UDI-DI
- 00816057020157 FDA UDI
- 510(k) Number
- K853857 FDA UDI
- FDA Product Code
- GTO 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
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
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: Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
ASI ASO Slide Test by Arlington Scientific, 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, reagent.
- K-ASSAY® ASO (WHO) Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- AIM ASO TEST — GERMAINE LABORATORIES, INC. · Class I
- ASI ASO Slide Test — Arlington Scientific, Inc. · Class I
- ASI ASO Slide Test — Arlington Scientific, Inc. · Class I
- ASI ASO Slide Test — Arlington Scientific, Inc. · Class I
- ASI Disposible Stirrer Pipet — Arlington Scientific, Inc. · Class I
- ASI ASO Slide Test — Arlington Scientific, Inc. · Class I
- ASI ASO Slide Test — Arlington Scientific, Inc. · Class I
Cleared under the same submission
K853857 also covers:
- ASI ASO Control Set — Arlington Scientific, Inc.
- ASI ASO Slide Test — Arlington Scientific, Inc.
- ASI ASO Slide Test — Arlington Scientific, Inc.
- ASI ASO Slide Test — Arlington Scientific, Inc.
- ASI ASO Slide Test — Arlington Scientific, Inc.
- ASI ASO Slide Test — Arlington Scientific, Inc.
- ASI ASO Slide Test — Arlington Scientific, Inc.
- ASI Disposable Stirrer Pipet — Arlington Scientific, Inc.
- ASI Disposible Stirrer Pipet — Arlington Scientific, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI 4e5f4fcb-ade1-40af-a982-ab596715bbaf 38 fields · synced Jul 18, 2026