Skip to content

N-Assay Tia Multi V-Nl

by Crestat Diagnostics, Inc. 510(k)

Active United States

510(k) K964300

Overview

The N-ASSAY TIA MULTI V-NL is a Complement C4, Antigen, Antiserum, Control device used as a calibration tool for specific Crestat N-Assay TIA test kits. It is designed for quantitative assays of proteins including C3, C4, Transferrin, Haptoglobin, and Alpha-1-Acid Glycoprotein in human serum.

It is intended for use in clinical laboratory settings by trained personnel to establish reference points for quantitative measurements. The device is supplied as a calibrator and is classified under FDA 510(k) clearance K964300 with product code DBI and regulation number 866.5240.

AI-generated from registry data, 24 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 NumberK964300 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 6 Oct 2026.

Specification

510(k)

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

Other devices from Crestat Diagnostics, Inc.

See all devices from Crestat Diagnostics, Inc. →

Questions

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

    The N-ASSAY TIA MULTI V-NL is used as a calibration tool for specific Crestat N-Assay TIA test kits to establish reference points for quantitative measurements of proteins including C3, C4, Transferrin, Haptoglobin, and Alpha-1-Acid Glycoprotein in human serum.

  • Who is intended to use the N-ASSAY TIA MULTI V-NL and where?

    The device is intended for use in clinical laboratory settings by trained personnel to perform quantitative assays and establish calibration reference points for protein measurements.

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

    The N-ASSAY TIA MULTI V-NL is supplied as a calibrator and is classified under FDA 510(k) clearance K964300 with product code DBI and regulation number 866.5240.