Quantimetrix Bilirubin Calibrators

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K895778 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Quantimetrix Urine Drugs of Abuse Control

  Class I

  FDA 510(k) K873467 Active Cleared 29 Sep 1987

• Quantimetrix Serum Alcohol Control Level 1 and 2

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  FDA 510(k) K873011 Active Cleared 29 Oct 1987

• Alkphor(Tm) System, Human Serum Alka Phos Isoenzy

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  FDA 510(k) K883395 Active Cleared 19 Sep 1988

• Quantimetrix Total Creatine Kinase Control

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  FDA 510(k) K874302 Active Cleared 2 Feb 1988

• Quantimetrix Serum Lipid Control I & II Liquid

  Class I

  FDA 510(k) K861448 Active Cleared 28 Apr 1986

• Lipophor(Tm) Syst, Human Serum Lipoprotein Control

  Class I

  FDA 510(k) K883247 Active Cleared 13 Sep 1988

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• What are Quantimetrix Bilirubin Calibrators used for?

  These primary calibrators are specifically designed to monitor the performance of neonatal bilirubin assay methods in clinical laboratory settings, ensuring accurate measurement of bilirubin levels when used with Reichert Unistat and Advanced Instruments BR2 Bilirubin Stat-Analyzer Model bilirubinometers.

• How are these calibrators supplied and what is their regulatory status?

  The calibrators are supplied for clinical chemistry applications and are classified under product code JIS. They are authorized under FDA 510(k) clearance K895778 as substantially equivalent, with a decision date of November 14, 1989, and are regulated under 862.1150.

• What is the purpose of using primary calibrators in bilirubin testing?

  Primary calibrators serve as reference materials to verify the accuracy and reliability of bilirubin measurement instruments, which is critical for proper diagnosis and treatment of neonatal jaundice. They help maintain consistent test results across different laboratory settings and over time.

• Which bilirubinometers are compatible with these calibrators?

  Quantimetrix Bilirubin Calibrators are specifically designed for use with Reichert Unistat and Advanced Instruments BR2 Bilirubin Stat-Analyzer Model bilirubinometers, ensuring proper calibration for these specific instruments in clinical laboratory environments.