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- 21 CFR 862.3300 · Digitoxin test system.
- 21 CFR 862.3320 · Digoxin test system.
- 21 CFR 862.3350 · Diphenylhydantoin test system.
- 21 CFR 862.3360 · Drug metabolizing enzyme genotyping system.
- 21 CFR 862.3364 · Pharmacogenetic assessment system.
- 21 CFR 862.3380 · Ethosuximide test system.
- 21 CFR 862.3450 · Gentamicin test system.
- 21 CFR 862.3460 · Plazomicin test system.
- 21 CFR 862.3520 · Kanamycin test system.
- 21 CFR 862.3550 · Lead test system.
- 21 CFR 862.3555 · Lidocaine test system.
- 21 CFR 862.3560 · Lithium test system.
- 21 CFR 862.3580 · Lysergic acid diethylamide (LSD) test system.
- 21 CFR 862.3590 · Meprobamate test system.
- 21 CFR 862.3600 · Mercury test system.
- 21 CFR 862.3610 · Methamphetamine test system.
- 21 CFR 862.3620 · Methadone test system.
- 21 CFR 862.3630 · Methaqualone test system.
- 21 CFR 862.3640 · Morphine test system.
- 21 CFR 862.3645 · Neuroleptic drugs radioreceptor assay test system.
- 21 CFR 862.3650 · Opiate test system.
- 21 CFR 862.3652 · Organophosphate test system.
- 21 CFR 862.3660 · Phenobarbital test system.
- 21 CFR 862.3670 · Phenothiazine test system.
- 21 CFR 862.3680 · Primidone test system.
- 21 CFR 862.3700 · Propoxyphene test system.
- 21 CFR 862.3750 · Quinine test system.
- 21 CFR 862.3800 · Reagents for molecular diagnostic instrument test systems.
- 21 CFR 862.3830 · Salicylate test system.
- 21 CFR 862.3840 · Sirolimus test system.
- 21 CFR 862.3850 · Sulfonamide test system.
- 21 CFR 862.3870 · Cannabinoid test system.
- 21 CFR 862.3880 · Theophylline test system.
- 21 CFR 862.3900 · Tobramycin test system.
- 21 CFR 862.3910 · Tricyclic antidepressant drugs test system.
- 21 CFR 862.3950 · Vancomycin test system.
- 21 CFR 862.3970 · Voriconazole test system.
- 21 CFR 864.1 · Scope.
- 21 CFR 864.3 · Effective dates of requirement for premarket approval.
- 21 CFR 864.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 864.1850 · Dye and chemical solution stains.
- 21 CFR 864.1860 · Immunohistochemistry reagents and kits.
- 21 CFR 864.1865 · Cervical intraepithelial neoplasia (CIN) test system.
- 21 CFR 864.1866 · Lynch syndrome test systems.
- 21 CFR 864.1870 · Early growth response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen characterization.
- 21 CFR 864.1880 · Fluorescence in situ hybridization (FISH)-based detection of chromosomal abnormalities from patients with hematologic malignancies.
- 21 CFR 864.1890 · In situ hybridization test systems for use with a corresponding approved oncology therapeutic product.
- 21 CFR 864.2220 · Synthetic cell and tissue culture media and components.
- 21 CFR 864.2240 · Cell and tissue culture supplies and equipment.
- 21 CFR 864.2260 · Chromosome culture kit.
- 21 CFR 864.2280 · Cultured animal and human cells.
- 21 CFR 864.2360 · Mycoplasma detection media and components.
- 21 CFR 864.2800 · Animal and human sera.
- 21 CFR 864.2875 · Balanced salt solutions or formulations.
- 21 CFR 864.3010 · Tissue processing equipment.
- 21 CFR 864.3250 · Specimen transport and storage container.
- 21 CFR 864.3260 · OTC test sample collection systems for drugs of abuse testing.
- 21 CFR 864.3300 · Cytocentrifuge.
- 21 CFR 864.3400 · Device for sealing microsections.
- 21 CFR 864.3600 · Microscopes and accessories.
- 21 CFR 864.3700 · Whole slide imaging system.
- 21 CFR 864.3750 · Software algorithm device to assist users in digital pathology.
- 21 CFR 864.3800 · Automated slide stainer.
- 21 CFR 864.3875 · Automated tissue processor.
- 21 CFR 864.4010 · General purpose reagent.
- 21 CFR 864.4020 · Analyte specific reagents.
- 21 CFR 864.4400 · Enzyme preparations.
- 21 CFR 864.5200 · Automated cell counter.
- 21 CFR 864.5220 · Automated differential cell counter.
- 21 CFR 864.5240 · Automated blood cell diluting apparatus.
- 21 CFR 864.5260 · Automated cell-locating device.
- 21 CFR 864.5300 · Red cell indices device.
- 21 CFR 864.5350 · Microsedimentation centrifuge.
- 21 CFR 864.5400 · Coagulation instrument.
- 21 CFR 864.5425 · Multipurpose system for in vitro coagulation studies.
- 21 CFR 864.5430 · Coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients.
- 21 CFR 864.5600 · Automated hematocrit instrument.
- 21 CFR 864.5620 · Automated hemoglobin system.
- 21 CFR 864.5680 · Automated heparin analyzer.
- 21 CFR 864.5700 · Automated platelet aggregation system.
- 21 CFR 864.5800 · Automated sedimentation rate device.
- 21 CFR 864.5850 · Automated slide spinner.
- 21 CFR 864.5950 · Blood volume measuring device.
- 21 CFR 864.6100 · Bleeding time device.
- 21 CFR 864.6150 · Capillary blood collection tube.
- 21 CFR 864.6160 · Manual blood cell counting device.
- 21 CFR 864.6400 · Hematocrit measuring device.
- 21 CFR 864.6550 · Occult blood test.
- 21 CFR 864.6600 · Osmotic fragility test.
- 21 CFR 864.6650 · Platelet adhesion test.
- 21 CFR 864.6675 · Platelet aggregometer.
- 21 CFR 864.6700 · Erythrocyte sedimentation rate test.
- 21 CFR 864.7010 · Flow cytometric test system for hematopoietic neoplasms.
- 21 CFR 864.7040 · Adenosine triphosphate release assay.
- 21 CFR 864.7060 · Antithrombin III assay.
- 21 CFR 864.7100 · Red blood cell enzyme assay.
- 21 CFR 864.7140 · Activated whole blood clotting time tests.
- 21 CFR 864.7250 · Erythropoietin assay.
- 21 CFR 864.7275 · Euglobulin lysis time tests.
- 21 CFR 864.7280 · Factor V Leiden DNA mutation detection systems.