Dade(R) Myoglobin Controls Tri-Level

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K922387 ↗

FDA Product Code

DDR

Device Class

Class II

Regulation

21 CFR Part 866.5680

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Bartels Prima System Advanced Screening Cartridge

  Class I

  FDA 510(k) K914202 Active Cleared 11 Oct 1991

• Bartels Herpes Simplex Virus 2 Igg Eia

  Class II

  FDA 510(k) K922583 Active Cleared 28 Sep 1992

• Dried Gram-Negative Mic/Combo Panels

  Class II

  FDA 510(k) K932082 Active Cleared 20 Jul 1993

• Paramax(R) Phenytoin Reagent

  Class II

  FDA 510(k) K932686 Active Cleared 26 Nov 1993

• Dried Gram Negative/Cefmetazole

  Class II

  FDA 510(k) K941317 Active Cleared 31 Jan 1995

• Parainfluenza Type 3 Ifa Test Kit for Anti. Detect

  Class I

  FDA 510(k) K884193 Active Cleared 22 Nov 1988

See all devices from Baxter Diagnostics, Inc. →

• What is the DADE(R) Myoglobin Controls Tri-Level used for?

  It is a diagnostic reagent designed for use in laboratory testing to detect myoglobin levels, functioning as a myoglobin antigen, antiserum, control device in immunology assays to ensure test accuracy and reliability.

• How is the DADE(R) Myoglobin Controls Tri-Level supplied and what does it contain?

  The device is supplied as a tri-level control set, meaning it includes three distinct concentration levels of myoglobin controls to monitor assay performance across low, medium, and high ranges in clinical laboratory settings.

• Is the DADE(R) Myoglobin Controls Tri-Level sterile or single-use?

  The device data does not specify sterility or single-use status; as a diagnostic reagent control set, it is intended for in vitro laboratory use and is not described as sterile or single-use in the provided information.