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Medica IIF Anti-Skin Antibody Test Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K902237

by Medica Corp.

Identifiers

510(k) Number
K902237 FDA 510(k)
FDA Product Code
DBL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5660 FDA 510(k)
Regulation Number
866.5660 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Medica IIF Anti-Skin Antibody Test Kit is an indirect immunofluorescent test device for the detection of multiple autoantibodies in human serum. It is classified as a Class II medical device under FDA regulation 866.5660 and is used in immunology testing.

The test kit is supplied as a diagnostic reagent system and is intended for use in clinical laboratory settings. It received FDA 510(k) clearance (K902237) on July 9, 1990, and is manufactured by Medica Corp. The device is not described as sterile, single-use, or reusable in the provided data, and no MRI safety, storage conditions, or size specifications are included.

Frequently asked questions

What is the Medica IIF Anti-Skin Antibody Test Kit used for?

The Medica IIF Anti-Skin Antibody Test Kit is used to detect multiple autoantibodies in human serum through an indirect immunofluorescent method. It is intended for immunology testing in clinical laboratory settings to aid in the identification of autoimmune skin conditions.

How is the Medica IIF Anti-Skin Antibody Test Kit supplied and what is its regulatory status?

The test kit is supplied as a diagnostic reagent system for use in clinical laboratories. It received FDA 510(k) clearance under K902237 on July 9, 1990, and is classified as a Class II medical device under regulation 866.5660, indicating it is substantially equivalent to a legally marketed predicate device.

Is the Medica IIF Anti-Skin Antibody Test Kit sterile, single-use, or reusable?

The provided data does not specify whether the Medica IIF Anti-Skin Antibody Test Kit is sterile, single-use, or reusable. No information about sterility, usage limitations, or reprocessing is included in the device specifications, so these details cannot be confirmed from the available data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT - Innolitics, Medica Iif Anti-skin Antibody Test Kit 510 (k) FDA Premarket ..., Device Listing 1159881004 - FDA.report, Medica, Inc. FDA 510 (k) Products (1999-1999), FDA Product Code DBL - Multiple Autoantibodies, Indirect ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medica Corp.

Sources (1)

  • FDA 510(k) K902237 24 fields · synced Oct 1, 2026