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ASI Color Staph Latex Test

FDA UDI

Class I (US FDA UDI)

by Arlington Scientific, Inc.

Identity

Trade Name
ASI Color Staph Latex Test FDA UDI
Generic Name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
Device Name
ASI Color Staph Latex Test 50 test kit FDA UDI
Model / Reference
NC-285-050 FDA UDI
Description
ASI Color Staph Latex Test 50 test kit FDA UDI

Identifiers

Catalog Number
NC-285-050 FDA UDI
Primary DI / UDI-DI
00816057021826 FDA UDI
510(k) Number
K830783 FDA UDI
FDA Product Code
JWX FDA UDI
GMDN Term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

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: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

ASI Color Staph Latex Test by Arlington Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Staphylococcus aureus culture isolate antigen IVD, kit, agglutination.

Cleared under the same submission

K830783 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 80fe0e5a-8f62-413c-8bdf-6ff594198a58 38 fields · synced Jul 18, 2026