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- 21 CFR 866.5870 · Thyroid autoantibody immunological test system.
- 21 CFR 866.5880 · Transferrin immunological test system.
- 21 CFR 866.5890 · Inter-alpha trypsin inhibitor immunological test system.
- 21 CFR 866.5900 · Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.
- 21 CFR 866.5910 · Quality control material for cystic fibrosis nucleic acid assays.
- 21 CFR 866.5920 · Postnatal chromosomal copy number variation detection system.
- 21 CFR 866.5930 · Newborn screening test for severe combined immunodeficiency disorder (SCID).
- 21 CFR 866.5940 · Autosomal recessive carrier screening gene mutation detection system.
- 21 CFR 866.5950 · Genetic health risk assessment system.
- 21 CFR 866.5960 · Human leukocyte antigen typing companion diagnostic test.
- 21 CFR 866.5970 · Inherited nucleotide repeat disorder DNA test.
- 21 CFR 866.5980 · Spinal Muscular Atrophy newborn screening test system.
- 21 CFR 866.6000 · Whole exome sequencing constituent device.
- 21 CFR 866.6010 · Tumor-associated antigen immunological test system.
- 21 CFR 866.6020 · Immunomagnetic circulating cancer cell selection and enumeration system.
- 21 CFR 866.6030 · AFP-L3% immunological test system.
- 21 CFR 866.6040 · Gene expression profiling test system for breast cancer prognosis.
- 21 CFR 866.6050 · Ovarian adnexal mass assessment score test system.
- 21 CFR 866.6060 · BCR-ABL quantitation test.
- 21 CFR 866.6070 · Mutation detection test for myeloproliferative neoplasms.
- 21 CFR 866.6080 · Next generation sequencing based tumor profiling test.
- 21 CFR 866.6090 · Cancer predisposition risk assessment system.
- 21 CFR 866.6095 · High throughput DNA sequencing for hereditary cancer predisposition assessment test system.
- 21 CFR 866.6100 · DNA-based test to measure minimal residual disease in hematological malignancies.
- 21 CFR 866.6110 · Circulating tumor cell enrichment device.
- 21 CFR 868.1 · Scope.
- 21 CFR 868.3 · Effective dates of requirement for premarket approval.
- 21 CFR 868.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 868.1030 · Manual algesimeter.
- 21 CFR 868.1040 · Powered algesimeter.
- 21 CFR 868.1075 · Argon gas analyzer.
- 21 CFR 868.1100 · Arterial blood sampling kit.
- 21 CFR 868.1120 · Indwelling blood oxyhemoglobin concentration analyzer.
- 21 CFR 868.1150 · Indwelling blood carbon dioxide partial pressure (P2CO2) analyzer.
- 21 CFR 868.1170 · Indwelling blood hydrogen ion concentration (pH) analyzer.
- 21 CFR 868.1200 · Indwelling blood oxygen partial pressure (PO2) analyzer.
- 21 CFR 868.1400 · Carbon dioxide gas analyzer.
- 21 CFR 868.1430 · Carbon monoxide gas analyzer.
- 21 CFR 868.1500 · Enflurane gas analyzer.
- 21 CFR 868.1505 · Ventilatory electrical impedance tomograph.
- 21 CFR 868.1575 · Gas collection vessel.
- 21 CFR 868.1620 · Halothane gas analyzer.
- 21 CFR 868.1640 · Helium gas analyzer.
- 21 CFR 868.1670 · Neon gas analyzer.
- 21 CFR 868.1690 · Nitrogen gas analyzer.
- 21 CFR 868.1700 · Nitrous oxide gas analyzer.
- 21 CFR 868.1720 · Oxygen gas analyzer.
- 21 CFR 868.1730 · Oxygen uptake computer.
- 21 CFR 868.1750 · Pressure plethysmograph.
- 21 CFR 868.1760 · Volume plethysmograph.
- 21 CFR 868.1780 · Inspiratory airway pressure meter.
- 21 CFR 868.1800 · Rhinoanemometer.
- 21 CFR 868.1840 · Diagnostic spirometer.
- 21 CFR 868.1850 · Monitoring spirometer.
- 21 CFR 868.1860 · Peak-flow meter for spirometry.
- 21 CFR 868.1870 · Gas volume calibrator.
- 21 CFR 868.1880 · Pulmonary-function data calculator.
- 21 CFR 868.1890 · Predictive pulmonary-function value calculator.
- 21 CFR 868.1900 · Diagnostic pulmonary-function interpretation calculator.
- 21 CFR 868.1910 · Esophageal stethoscope.
- 21 CFR 868.1920 · Esophageal stethoscope with electrical conductors.
- 21 CFR 868.1930 · Stethoscope head.
- 21 CFR 868.1965 · Switching valve (ploss).
- 21 CFR 868.1975 · Water vapor analyzer.
- 21 CFR 868.1980 · Real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia.
- 21 CFR 868.2025 · Ultrasonic air embolism monitor.
- 21 CFR 868.2200 · Adjunctive pain measurement device for anesthesiology.
- 21 CFR 868.2250 · Monitor for opioid induced impairment of oxygenation.
- 21 CFR 868.2300 · Bourdon gauge flowmeter.
- 21 CFR 868.2320 · Uncompensated thorpe tube flowmeter.
- 21 CFR 868.2340 · Compensated thorpe tube flowmeter.
- 21 CFR 868.2350 · Gas calibration flowmeter.
- 21 CFR 868.2375 · Breathing frequency monitor.
- 21 CFR 868.2376 · Device for sleep apnea testing based on mandibular movement.
- 21 CFR 868.2377 · Apnea monitor.
- 21 CFR 868.2380 · Nitric oxide analyzer.
- 21 CFR 868.2385 · Nitrogen dioxide analyzer.
- 21 CFR 868.2450 · Lung water monitor.
- 21 CFR 868.2480 · Cutaneous carbon dioxide (PcCO2) monitor.
- 21 CFR 868.2500 · Cutaneous oxygen (PcO2) monitor.
- 21 CFR 868.2550 · Pneumotachometer.
- 21 CFR 868.2600 · Airway pressure monitor.
- 21 CFR 868.2610 · Gas pressure gauge.
- 21 CFR 868.2620 · Gas pressure calibrator.
- 21 CFR 868.2700 · Pressure regulator.
- 21 CFR 868.2775 · Electrical peripheral nerve stimulator.
- 21 CFR 868.2875 · Differential pressure transducer.
- 21 CFR 868.2885 · Gas flow transducer.
- 21 CFR 868.2900 · Gas pressure transducer.
- 21 CFR 868.5090 · Emergency airway needle.
- 21 CFR 868.5095 · Retrograde intubation device.
- 21 CFR 868.5100 · Nasopharyngeal airway.
- 21 CFR 868.5105 · External negative pressure airway aid.
- 21 CFR 868.5110 · Oropharyngeal airway.
- 21 CFR 868.5115 · Device to relieve acute upper airway obstruction.
- 21 CFR 868.5120 · Anesthesia conduction catheter.
- 21 CFR 868.5130 · Anesthesia conduction filter.
- 21 CFR 868.5140 · Anesthesia conduction kit.
- 21 CFR 868.5150 · Anesthesia conduction needle.
- 21 CFR 868.5160 · Gas machine for anesthesia or analgesia.