Multi-Analyte Controls Unassayed
The Multi-Analyte Controls Unassayed is a quality control material intended for use in clinical laboratory test systems to estimate test precision and detect systematic analytical deviations arising from reagent or instrument variation across multiple analytes; it may also be used for proficiency testing in interlaboratory surveys. Classified as FDA Class 1 under regulation 21 CFR 862.1660 within the Clinical Chemistry medical specialty, it is subject to general controls only, though it is not GMP-exempt. The product code is OHQ. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OHQ
- Device Class
- FDA class 1
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
Definition
A quality control material (unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (unassayed) for blood gases, electrolytes, enzymes, multianalytes, single (specified) analytes, or urinalysis controls.
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.