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  1. LII
  2. Electronic Code of Federal Regulations (e-CFR)
  3. Title 21—Food and Drugs
  4. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  5. SUBCHAPTER H—MEDICAL DEVICES
  6. PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
  7. Subpart B—Biological Stains

21 CFR Part 864 - Subpart B - Biological Stains

  • CFR
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  1. § 864.1850 Dye and chemical solution stains.
  2. § 864.1860 Immunohistochemistry reagents and kits.
  3. § 864.1865 Cervical intraepithelial neoplasia (CIN) test system.
  4. § 864.1866 Lynch syndrome test systems.
  5. § 864.1870 Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
  6. § 864.1880 Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.

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