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IVD Technologies Achrab Test Kit

by Ivd Technologies

510(k) K091468

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 NumberK091468 Date20 Nov 2009ClearedStatusActive

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  • Withdrawn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, 23 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 an in vitro diagnostic test kit for the detection of autoantibodies to the acetylcholine receptor, including both blocking and non-blocking antibodies. It is used to aid in the diagnosis of myasthenia gravis by measuring acetylcholine receptor autoantibodies in patient serum.

The test kit is supplied for in vitro diagnostic use is manufactured by Ivd Technologies and received FDA 510(k) clearance under k-number K091468. It is classified as a Class II device with product code NST and regulation number 866.5660, and is intended for use in immunology laboratory settings.

Questions

AI-generated answers, 23 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 IVD Technologies ACHRAB Test Kit used for?

    The IVD Technologies ACHRAB Test Kit is used to detect autoantibodies to the acetylcholine receptor, including both blocking and non-blocking types, in patient serum. This aids in the diagnosis of myasthenia gravis by measuring the presence of these autoantibodies, which are associated with the autoimmune disorder affecting neuromuscular transmission.

  • How is the IVD Technologies ACHRAB Test Kit supplied and intended for use?

    The test kit is supplied for in vitro diagnostic use and is intended for use in immunology laboratory settings. It is manufactured by Ivd Technologies and designed to process patient serum samples to detect acetylcholine receptor autoantibodies, supporting clinical diagnosis of myasthenia gravis through laboratory testing.

  • What regulatory clearance does the IVD Technologies ACHRAB Test Kit have?

    The IVD Technologies ACHRAB Test Kit received FDA 510(k) clearance under k-number K091468. It is classified as a Class II device with product code NST and regulation number 866.5660, and was determined to be substantially equivalent to a predicate device through a traditional 510(k) submission.