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FITC Anti-Rabies Monoclonal Globulin

by Centocor, Inc.

510(k) K820499

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 NumberK820499 Date16 Apr 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  • Withdrawn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
GOI
Device Class
Class II
Regulation
21 CFR Part 866.3460
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a fluorescent monoclonal antibody reagent classified as an antiserum, specifically designed for in vitro diagnostic use. It is intended for the direct fluorescent antibody (FA) procedure to detect rabies virus and lyssaviruses in animal tissues, including brain and submaxillary gland samples.

The FITC Anti-Rabies Monoclonal Globulin is supplied as a diagnostic reagent for laboratory use and is regulated under FDA 510(k) clearance (K820499) with a product code of GOI. It is intended for single-use in microbiology settings and requires proper storage and handling as outlined in the accompanying instructions. No additional regulatory status beyond the stated 510(k) clearance is implied.

Other devices from Centocor, Inc.

Questions

AI-generated answers, 19 Sep 2026

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

  • What is the primary use of the FITC Anti-Rabies Monoclonal Globulin in a laboratory setting?

    This reagent is specifically designed for the direct fluorescent antibody (FA) procedure to detect rabies virus and related lyssaviruses in animal tissues, such as brain or submaxillary gland samples. It helps identify viral presence through fluorescence, enabling accurate diagnostic testing in microbiology labs.

  • Is this product intended for single-use or repeated use in testing?

    The FITC Anti-Rabies Monoclonal Globulin is supplied for single-use only in microbiology settings. This ensures sterility and reliability for each diagnostic procedure, as outlined in the accompanying instructions.

  • How should this reagent be stored, and are there any special handling requirements?

    While exact storage conditions are detailed in the provided instructions, the reagent requires proper storage and handling to maintain its integrity. Since it is a diagnostic reagent, it should be kept in a controlled environment to prevent degradation, typically away from direct light and extreme temperatures.

  • What regulatory pathway was followed for this device’s clearance, and which committee reviewed it?

    The FITC Anti-Rabies Monoclonal Globulin was cleared through the FDA’s 510(k) process under the Microbiology advisory committee (MI). The submission was classified as substantially equivalent (SESE) and received clearance on April 16, 1982, with the product code GOI.