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Calibrator, Bovine Serum

by Bio-Reagents & Diagnostics, Inc.

510(k) K781702

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781702 Date15 Nov 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JIX
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

A calibrator, bovine serum is a device used to establish a reference point for the quantitative measurement of analytes in clinical chemistry assays. It is prepared from bovine serum and is intended for use in laboratory settings to ensure the accuracy and reliability of test results.

This device is supplied as a liquid reagent and is intended for in vitro diagnostic use. It is a single-use product that requires appropriate storage conditions as specified by the manufacturer. The device received FDA 510(k) clearance (K781702) on November 15, 1978, and is classified as a Class II medical device under regulation number 862.1150.

Other devices from Bio-Reagents & Diagnostics, Inc.

Questions

AI-generated answers, 25 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 CALIBRATOR, BOVINE SERUM used for?

    It is used to establish a reference point for the quantitative measurement of analytes in clinical chemistry assays, ensuring the accuracy and reliability of test results by providing a known standard derived from bovine serum.

  • How is the CALIBRATOR, BOVINE SERUM supplied and is it single-use or reusable?

    The device is supplied as a liquid reagent and is intended for single-use only, meaning it should be discarded after one application to prevent contamination and maintain measurement integrity in laboratory settings.

  • What storage conditions are required for the CALIBRATOR, BOVINE SERUM?

    It requires appropriate storage conditions as specified by the manufacturer to maintain stability and performance; users must follow the storage instructions provided with the product to ensure the calibrator remains effective for its intended use.