Non-Mercuric Chloride Reagent

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Intersect Systems' Non-Mercuric Chloride Reagent

510(k) Number

K941807 ↗

FDA Product Code

CHG

Device Class

Class II

Regulation

21 CFR Part 862.1170

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K870616 Active Cleared 6 Mar 1987

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  FDA 510(k) K932888 Active Cleared 31 Jan 1994

• Intersect Systems Triglyceride-Gpo Reagent

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  FDA 510(k) K870827 Active Cleared 13 Mar 1987

• Enzymatic CO2 Reagent, Modification

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• Carbon Dioxide Reagent

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• Mini-Pecg

  Class II

  FDA 510(k) K832883 Active Cleared 6 Dec 1983

See all devices from Intersect Systems, Inc. →

• What types of biological specimens can this reagent be used to measure chloride ions in, and why is this important for clinical use?

  This reagent is specifically designed for quantitative measurement of chloride ions in plasma, serum, sweat, and urine. Chloride levels in these specimens are critical for diagnosing electrolyte imbalances, metabolic disorders, and conditions like cystic fibrosis (via sweat testing) or renal dysfunction. Accurate chloride measurement helps clinicians assess hydration status, acid-base balance, and overall metabolic health.

• Is this reagent single-use, and if so, why does that matter for laboratory workflows?

  Yes, this reagent is supplied as a single-use chemical reagent. This design ensures consistency in test results by preventing cross-contamination between samples, which is essential for reliable diagnostic accuracy. Single-use also reduces the risk of microbial contamination and eliminates the need for cleaning or sterilization between uses, simplifying laboratory workflows and minimizing waste.

• What storage requirements apply to this reagent, and how does that affect its usability in clinical settings?

  The reagent requires no special storage conditions beyond those outlined in the accompanying documentation. This means it can be stored under standard laboratory conditions (typically room temperature or refrigerated, depending on the documentation), making it convenient for clinical settings without requiring specialized infrastructure. This flexibility ensures accessibility for laboratories of varying sizes and resources.

• How is this reagent different from traditional chloride reagents, and why might clinicians prefer this version?

  This reagent is explicitly labeled as *non-mercuric*, meaning it does not contain mercury—a toxic heavy metal found in some older chloride reagents. Clinicians may prefer this version to avoid mercury exposure risks for lab personnel and to comply with environmental and workplace safety regulations. The non-mercuric formulation maintains accuracy while prioritizing safety and sustainability.

• What kind of equipment is required to use this reagent, and how does that impact its compatibility with existing lab setups?

  This reagent is designed for use exclusively with *spectrophotometric analyzers*, which are standard in clinical chemistry laboratories. Since spectrophotometry is a widely adopted technology, most modern labs already have compatible equipment. This ensures seamless integration without requiring additional investments, making it a practical choice for routine electrolyte testing.