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Easy Lab Pro RSV

FDA UDI

Class I (US FDA UDI)

by American Bio Medica Corp.

Identity

Trade Name
Easy Lab Pro RSV FDA UDI
Generic Name
Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator FDA UDI
Device Name
Easy Lab Pro RSV - US FDA UDI
Model / Reference
10-RSV-ELP FDA UDI
Description
Easy Lab Pro RSV - US FDA UDI

Identifiers

Catalog Number
10-RSV-ELP FDA UDI
Primary DI / UDI-DI
10694644700036 FDA UDI
510(k) Number
K021789 FDA UDI
FDA Product Code
GQG FDA UDI
GMDN Term
Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3480 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator

Easy Lab Pro RSV by American Bio Medica Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator.

Cleared under the same submission

K021789 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Bio Medica Corp.

Sources (1)

  • FDA UDI 08bea8b6-dd1e-4127-8b5a-35ff2e30f5d2 37 fields · synced May 30, 2026