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21 C.F.R. · Food and Drugs
21 C.F.R. § 864.8150

Calibrator for cell indices.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 864.8150 — Calibrator for cell indices.

§ 864.8150 Calibrator for cell indices. (a) Identification. A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. [45 FR 60631, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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BS-CFR21-SEC-8F1EB3
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boisestandard.org
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21 C.F.R. § 864.8150
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CFR — Code of Federal Regulations
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The regulatory text of 21 C.F.R. § 864.8150 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
Navigate Corpus — Title 21 C.F.R.
← 21 C.F.R. § 864.8100 21 C.F.R. § 864.8165 →
Title 21 — Food and Drugs
21 C.F.R. § 1.121 C.F.R. § 1.321 C.F.R. § 1.421 C.F.R. § 1.2021 C.F.R. § 1.2121 C.F.R. § 1.2321 C.F.R. § 1.2421 C.F.R. § 1.7021 C.F.R. § 1.7121 C.F.R. § 1.7221 C.F.R. § 1.7321 C.F.R. § 1.7421 C.F.R. § 1.7521 C.F.R. § 1.7621 C.F.R. § 1.7721 C.F.R. § 1.7821 C.F.R. § 1.7921 C.F.R. § 1.8021 C.F.R. § 1.8121 C.F.R. § 1.8321 C.F.R. § 1.9021 C.F.R. § 1.9121 C.F.R. § 1.9421 C.F.R. § 1.9521 C.F.R. § 1.9621 C.F.R. § 1.9721 C.F.R. § 1.9921 C.F.R. § 1.10121 C.F.R. § 1.22521 C.F.R. § 1.226
21 C.F.R. — public domain ← All Legislation
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