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21 C.F.R. · Food and Drugs
21 C.F.R. § 864.7720

Prothrombin consumption test.

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

21 C.F.R. § 864.7720 — Prothrombin consumption test.

§ 864.7720 Prothrombin consumption test. (a) Identification. A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B. (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 60625, 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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◈ Machine-Readable Provenance Record Root-LD v1.0 · boisestandard.org
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BS-CFR21-SEC-EF82F0
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 864.7720
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CFR — Code of Federal Regulations
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PRIMARY-SOURCE
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The regulatory text of 21 C.F.R. § 864.7720 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. § 864.7695 21 C.F.R. § 864.7735 →
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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boisestandard.org → United States → Law → CFR → Title 21 → 21 C.F.R. § 864.7720