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Cortisol-RIA Coated Tube Radioimmunoassay Kit

by Canadian Bioclinical, Ltd.

510(k) K870969

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870969 Date22 Jun 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Cortisol-Ria Kit Coated Tube Radioimmunoassay Kit
510(k) Number
FDA Product Code
CGR
Device Class
Class II
Regulation
21 CFR Part 862.1205
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Cortisol-RIA Coated Tube Radioimmunoassay Kit is a diagnostic in vitro device designed for the quantitative measurement of cortisol in human serum, plasma, and urine samples. It employs a coated tube radioimmunoassay method to provide precise and sensitive detection of cortisol levels, aiding in the evaluation of adrenal function and stress response. This device is classified under the FDA’s radioimmunoassay category for cortisol and is intended for use in clinical chemistry laboratories.

This single-use kit has received FDA 510(k) clearance (K870969) and is classified under product code CGR, adhering to regulation 862.1205. It is not MRI-compatible due to the presence of radioactive materials. Each kit contains 96 tests and has an 8-week shelf life from the date of manufacture. Storage must comply with manufacturer instructions to ensure assay validity.

Cortisol-RIA Coated Tube Radioimmunoassay Kit

Other devices from Canadian Bioclinical, Ltd.

Questions

AI-generated answers, 1 Oct 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 Cortisol-RIA Coated Tube Radioimmunoassay Kit used for?

    This kit is designed for the precise quantitative measurement of cortisol levels in human serum, plasma, and urine samples. Cortisol testing aids in evaluating adrenal function and assessing stress responses, making it useful in clinical chemistry laboratories for diagnostic purposes.

  • How is the Cortisol-RIA Coated Tube Radioimmunoassay Kit supplied, and is it single-use?

    Each kit contains 96 tests and is intended for single-use only. The coated tube radioimmunoassay method ensures accurate cortisol detection per test, and the kit’s design prevents reuse to maintain assay validity and safety.

  • What is the shelf life of the kit, and how should it be stored?

    The kit has an 8-week shelf life from the date of manufacture. Storage must strictly follow the manufacturer’s instructions to preserve assay accuracy and prevent degradation of components, particularly given the presence of radioactive materials.

  • Is this kit compatible with MRI machines?

    No, the kit is not MRI-compatible due to the inclusion of radioactive materials. Exposure to MRI environments could compromise safety and assay integrity, so it must be handled and stored in non-MRI areas.

  • What regulatory clearance does the Cortisol-RIA Coated Tube Radioimmunoassay Kit hold?

    The kit holds FDA 510(k) clearance (K870969) under product code CGR, classified under regulation 862.1205. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for radioimmunoassay-based cortisol testing.