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Antiserum To Human Igg

by Amico Lab, Inc.

510(k) K822669

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822669 Date17 Nov 1982ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DFH
Device Class
Class II
Regulation
21 CFR Part 866.5550
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Antiserum to Human Igg is an immunology laboratory reagent used for detecting and quantifying human immunoglobulin G (IgG) proteins. It is produced by immunizing goats with human IgG to generate antibodies that specifically bind to human IgG molecules.

This device is supplied as a 2ml liquid formulation and is intended for laboratory use. It is a Class II medical device with FDA 510(k) clearance (K822669) under product code DFH. The antiserum has been tested for specificity using immunoelectrophoresis and shows reactivity to human IgG, though cross-reactivity to other species may occur.

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