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- 21 CFR 862.1560 · Urinary phenylketones (nonquantitative) test system.
- 21 CFR 862.1565 · 6-Phosphogluconate dehydrogenase test system.
- 21 CFR 862.1570 · Phosphohexose isomerase test system.
- 21 CFR 862.1575 · Phospholipid test system.
- 21 CFR 862.1580 · Phosphorus (inorganic) test system.
- 21 CFR 862.1585 · Human placental lactogen test system.
- 21 CFR 862.1590 · Porphobilinogen test system.
- 21 CFR 862.1595 · Porphyrins test system.
- 21 CFR 862.1600 · Potassium test system.
- 21 CFR 862.1602 · Prognostic test for development or progression of preeclampsia.
- 21 CFR 862.1605 · Pregnanediol test system.
- 21 CFR 862.1610 · Pregnanetriol test system.
- 21 CFR 862.1615 · Pregnenolone test system.
- 21 CFR 862.1620 · Progesterone test system.
- 21 CFR 862.1622 · Prognostic test for assessment of liver related disease progression.
- 21 CFR 862.1625 · Prolactin (lactogen) test system.
- 21 CFR 862.1630 · Protein (fractionation) test system.
- 21 CFR 862.1635 · Total protein test system.
- 21 CFR 862.1640 · Protein-bound iodine test system.
- 21 CFR 862.1645 · Urinary protein or albumin (nonquantitative) test system.
- 21 CFR 862.1650 · Pyruvate kinase test system.
- 21 CFR 862.1655 · Pyruvic acid test system.
- 21 CFR 862.1660 · Quality control material (assayed and unassayed).
- 21 CFR 862.1665 · Sodium test system.
- 21 CFR 862.1670 · Sorbitol dehydrogenase test system.
- 21 CFR 862.1675 · Blood specimen collection device.
- 21 CFR 862.1676 · Blood collection device for cell-free nucleic acids.
- 21 CFR 862.1678 · Tacrolimus test system.
- 21 CFR 862.1680 · Testosterone test system.
- 21 CFR 862.1685 · Thyroxine-binding globulin test system.
- 21 CFR 862.1690 · Thyroid stimulating hormone test system.
- 21 CFR 862.1695 · Free thyroxine test system.
- 21 CFR 862.1700 · Total thyroxine test system.
- 21 CFR 862.1705 · Triglyceride test system.
- 21 CFR 862.1710 · Total triiodothyronine test system.
- 21 CFR 862.1715 · Triiodothyronine uptake test system.
- 21 CFR 862.1720 · Triose phosphate isomerase test system.
- 21 CFR 862.1725 · Trypsin test system.
- 21 CFR 862.1730 · Free tyrosine test system.
- 21 CFR 862.1770 · Urea nitrogen test system.
- 21 CFR 862.1775 · Uric acid test system.
- 21 CFR 862.1780 · Urinary calculi (stones) test system.
- 21 CFR 862.1785 · Urinary urobilinogen (nonquantitative) test system.
- 21 CFR 862.1790 · Uroporphyrin test system.
- 21 CFR 862.1795 · Vanilmandelic acid test system.
- 21 CFR 862.1805 · Vitamin A test system.
- 21 CFR 862.1810 · Vitamin B12 test system.
- 21 CFR 862.1815 · Vitamin E test system.
- 21 CFR 862.1820 · Xylose test system.
- 21 CFR 862.1825 · Vitamin D test system.
- 21 CFR 862.1840 · Total 25-hydroxyvitamin D mass spectrometry test system.
- 21 CFR 862.2050 · General purpose laboratory equipment labeled or promoted for a specific medical use.
- 21 CFR 862.2100 · Calculator/data processing module for clinical use.
- 21 CFR 862.2120 · Continuous glucose monitor data management system.
- 21 CFR 862.2140 · Centrifugal chemistry analyzer for clinical use.
- 21 CFR 862.2150 · Continuous flow sequential multiple chemistry analyzer for clinical use.
- 21 CFR 862.2160 · Discrete photometric chemistry analyzer for clinical use.
- 21 CFR 862.2170 · Micro chemistry analyzer for clinical use.
- 21 CFR 862.2230 · Chromatographic separation material for clinical use.
- 21 CFR 862.2250 · Gas liquid chromatography system for clinical use.
- 21 CFR 862.2260 · High pressure liquid chromatography system for clinical use.
- 21 CFR 862.2265 · High throughput genomic sequence analyzer for clinical use.
- 21 CFR 862.2270 · Thin-layer chromatography system for clinical use.
- 21 CFR 862.2300 · Colorimeter, photometer, or spectrophotometer for clinical use.
- 21 CFR 862.2310 · Clinical sample concentrator.
- 21 CFR 862.2320 · Beta or gamma counter for clinical use.
- 21 CFR 862.2400 · Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
- 21 CFR 862.2485 · Electrophoresis apparatus for clinical use.
- 21 CFR 862.2500 · Enzyme analyzer for clinical use.
- 21 CFR 862.2540 · Flame emission photometer for clinical use.
- 21 CFR 862.2560 · Fluorometer for clinical use.
- 21 CFR 862.2570 · Instrumentation for clinical multiplex test systems.
- 21 CFR 862.2680 · Microtitrator for clinical use.
- 21 CFR 862.2700 · Nephelometer for clinical use.
- 21 CFR 862.2720 · Plasma oncometer for clinical use.
- 21 CFR 862.2730 · Osmometer for clinical use.
- 21 CFR 862.2750 · Pipetting and diluting system for clinical use.
- 21 CFR 862.2800 · Refractometer for clinical use.
- 21 CFR 862.2850 · Atomic absorption spectrophotometer for clinical use.
- 21 CFR 862.2860 · Mass spectrometer for clinical use.
- 21 CFR 862.2900 · Automated urinalysis system.
- 21 CFR 862.2920 · Plasma viscometer for clinical use.
- 21 CFR 862.3030 · Acetaminophen test system.
- 21 CFR 862.3035 · Amikacin test system.
- 21 CFR 862.3040 · Alcohol test system.
- 21 CFR 862.3050 · Breath-alcohol test system.
- 21 CFR 862.3080 · Breath nitric oxide test system.
- 21 CFR 862.3100 · Amphetamine test system.
- 21 CFR 862.3110 · Antimony test system.
- 21 CFR 862.3115 · Anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease.
- 21 CFR 862.3120 · Arsenic test system.
- 21 CFR 862.3150 · Barbiturate test system.
- 21 CFR 862.3170 · Benzodiazepine test system.
- 21 CFR 862.3200 · Clinical toxicology calibrator.
- 21 CFR 862.3220 · Carbon monoxide test system.
- 21 CFR 862.3240 · Cholinesterase test system.
- 21 CFR 862.3245 · Clozapine test system.
- 21 CFR 862.3250 · Cocaine and cocaine metabolite test system.
- 21 CFR 862.3270 · Codeine test system.
- 21 CFR 862.3280 · Clinical toxicology control material.