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Acetylcholine Receptor AB (ARAB)RRA

by Ibl-Hamburg GmbH

510(k) K051144

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 NumberK051144 Date18 Nov 2005ClearedStatusActive

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  • Withdrawn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
NST
Device Class
Class II
Regulation
21 CFR Part 866.5660
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.

The Acetylcholine Receptor AB (ARAB)RRA is a medical device used for detecting autoantibodies to acetylcholine receptors. This device is classified under immunology and is designed to identify both acetylcholine blocking and non-blocking autoantibodies in patient samples.

The device is supplied by Ibl-Hamburg GmbH and has received FDA 510(k) clearance with the product code NST. It is a Class II device regulated under number 866.5660 and is intended for laboratory use in immunology testing. The device is not specified as single-use or reusable, and no information regarding sterility or MRI safety is provided in the data.

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Questions

AI-generated answers, 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.

  • What is the purpose of the ACETYLCHOLINE RECEPTOR AB (ARAB)RRA device?

    The ACETYLCHOLINE RECEPTOR AB (ARAB)RRA is a medical device used for detecting autoantibodies to acetylcholine receptors. It is designed to identify both acetylcholine blocking and non-blocking autoantibodies in patient samples for laboratory immunology testing.

  • How is the ACETYLCHOLINE RECEPTOR AB (ARAB)RRA supplied and what is its regulatory status?

    The device is supplied by Ibl-Hamburg GmbH and has received FDA 510(k) clearance with the product code NST. It is classified as a Class II device regulated under number 866.5660 and is intended for laboratory use in immunology testing.

  • Is the ACETYLCHOLINE RECEPTOR AB (ARAB)RRA single-use or reusable?

    The device data does not specify whether the ACETYLCHOLINE RECEPTOR AB (ARAB)RRA is single-use or reusable. No information regarding sterility or MRI safety is provided in the available specifications.

  • What advisory committee reviewed the ACETYLCHOLINE RECEPTOR AB (ARAB)RRA device?

    The ACETYLCHOLINE RECEPTOR AB (ARAB)RRA device was reviewed by the Immunology (IM) advisory committee. The device received a decision code of SESE (Substantially Equivalent) on 2005-11-18, with the application initially received on 2005-05-04.