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ASI RF Direct Slide Test

FDA UDI

Class II (US FDA UDI)

by Arlington Scientific, Inc.

Identity

Trade Name
ASI RF Direct Slide Test FDA UDI
Generic Name
Poliovirus antigen (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Detection of Rheumatoid Factor FDA UDI
Model / Reference
NC-700100DC FDA UDI
Description
Detection of Rheumatoid Factor FDA UDI

Identifiers

Catalog Number
NC-700100DC FDA UDI
Primary DI / UDI-DI
00816057020485 FDA UDI
510(k) Number
K821319 FDA UDI
FDA Product Code
DHR FDA UDI
GMDN Term
Poliovirus antigen (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5775 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: Poliovirus antigen (serotypes PV1-PV3) IVD, kit, enzyme immunoassay (EIA)

ASI RF Direct Slide Test by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K821319 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arlington Scientific, Inc.

Sources (1)

  • FDA UDI 88a23d61-1d73-4ca5-9681-61414f0905f9 38 fields · synced Jul 18, 2026