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N-Assay Tia Multi V-Nl

by Crestat Diagnostics, Inc. 510(k)

Active United States

510(k) K964298

Overview

The N-ASSAY TIA MULTI V-NL is a Complement C3, Antigen, Antiserum, Control device used in immunology testing. It is classified as a Class II medical device under product code CZW and regulation number 866.5240.

The device received FDA 510(k) clearance (K964298) on July 14, 1997, following a traditional review process. It was found to be substantially equivalent to a predicate device and is manufactured by Crestat Diagnostics, Inc. in Murrieta, California.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK964298 Date14 Jul 1997ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CZW
Device Class
Class II
Regulation
21 CFR Part 866.5240
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the N-ASSAY TIA MULTI V-NL used for?

    The N-ASSAY TIA MULTI V-NL is used as a Complement C3, Antigen, Antiserum, Control device in immunology testing to support the measurement of Complement C3 antigen levels in patient samples, serving as a quality control reagent to ensure assay accuracy and reproducibility.

  • How is the N-ASSAY TIA MULTI V-NL supplied and what is its format?

    The device is supplied as a liquid antiserum control formulation intended for use in laboratory immunology assays; it is provided in a ready-to-use liquid format for direct addition to test systems, though specific vial size or volume is not detailed in the authorization data.

  • Is the N-ASSAY TIA MULTI V-NL sterile or single-use?

    The device data does not specify sterility or single-use status; as a control antiserum for in vitro diagnostic use, it is typically non-sterile and intended for multiple uses within its stability period, but users should consult the product labeling for exact handling and storage instructions.

  • What regulatory pathway was used for the N-ASSAY TIA MULTI V-NL?

    The N-ASSAY TIA MULTI V-NL received FDA 510(k) clearance under submission K964298 on July 14, 1997, following a traditional review process, and was determined to be substantially equivalent to a legally marketed predicate device under product code CZW and regulation 866.5240.