Identity
- Trade Name
- ASI Disposable Stirrer Pipet FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent FDA UDI
- Device Name
- Disposable Pipet, 100/bag FDA UDI
- Model / Reference
- NC-5071-002-100 FDA UDI
- Description
- Disposable Pipet, 100/bag FDA UDI
Identifiers
- Catalog Number
- NC-5071-002-100 FDA UDI
- Primary DI / UDI-DI
- 00816057021178 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.03 Milliliter FDA UDI
Category: Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
ASI Disposable Stirrer Pipet by Arlington Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent.
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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 ASO Slide Test — 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 |
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Manufacturer
- Manufacturer
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI bb1db1cd-e530-44f2-a46b-ab9df4aae04d 38 fields · synced Jul 18, 2026