# Pembagian Kelas Alkes Per Kategori
# Pembagian Kelas Alkes Per Kategori
# Pembagian Kelas Alkes Per Kategori
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use I
§ 862.2100 Calculator/data processing module for clinical use I
§ 862.2140 Centrifugal chemistry analyzer for clinical use I
§ 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use I
§ 862.2160 Discrete photometric chemistry analyzer for clinical use I
§ 862.2170 Micro chemistry analyzer for clinical use I
§ 862.2230 Chromatographic separation material for clinical use I
§ 862.2250 Gas liquid chromatography system for clinical use. I
§ 862.2260 High pressure liquid chromatography system for clinical use I
§ 862.2270 Thin-layer chromatography system for clinical use. I
§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use I
§ 862.2310 Clinical sample concentrator. I
§ 862.2320 Beta or gamma counter for clinical use. I
§ 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. I
§ 862.2485 Electrophoresis apparatus for clinical use I
§ 862.2500 Enzyme analyzer for clinical use. I
§ 862.2540 Flame emission photometer for clinical use I
§ 862.2560 Fluorometer for clinical use I
§ 862.2680 Microtitrator for clinical use I
§ 862.2700 Nephelometer for clinical use. I
§ 862.2720 Plasma oncometer for clinical use I
§ 862.2730 Osmometer for clinical use I
§ 862.2750 Pipetting and diluting system for clinical use. I
§ 862.2800 Refractometer for clinical use I
§ 862.2850 Atomic absorption spectrophotometer for clinical use I
§ 862.2860 Mass spectrometer for clinical use. I
§ 862.2900 Automated urinalysis system I
§ 862.2920 Plasma viscometer for clinical use. I
§ 862.2570 Instrumentation for clinical multiplex test systems II
2.9 PRODUK YANG DIGUNAKAN DALAM PEMBUATAN SEDIAAN DARAH DAN SEDIAAN BERASAL DARI DARAH
5. PERALATAN KARDIOLOGI
§ 870.1025 - Arrhythmia detector and alarm (including ST-segment measurement and alarm). II
§ 870.1100 - Blood pressure alarm. II
§ 870.1110 - Blood pressure computer. II
§ 870.1120 - Blood pressure cuff. II
§ 870.1130 - Noninvasive blood pressure measurement system. II
§ 870.1140 - Venous blood pressure manometer. II
§ 870.1200 - Diagnostic intravascular catheter. II
§ 870.1210 - Continuous flush catheter. II
§ 870.1220 - Electrode recording catheter or electrode recording probe. II
§ 870.1230 - Fiberoptic oximeter catheter. II
§ 870.1240 - Flow-directed catheter. II
§ 870.1250 - Percutaneous catheter. II
§ 870.1270 - Intracavitary phonocatheter system. II
§ 870.1280 - Steerable catheter. II
§ 870.1290 - Steerable catheter control system. II
§ 870.1300 - Catheter cannula. II
§ 870.1310 - Vessel dilator for percutaneous catheterization. II
§ 870.1330 - Catheter guide wire. II
§ 870.1340 - Catheter introducer. II
§ 870.1350 - Catheter balloon repair kit. III
§ 870.1360 - Trace microsphere. III
§ 870.1370 - Catheter tip occluder. II
§ 870.1380 - Catheter stylet. II
§ 870.1390 - Trocar. II
§ 870.1425 - Programmable diagnostic computer. II
§ 870.1435 - Single-function, preprogrammed diagnostic computer. II
§ 870.1450 - Densitometer. II
§ 870.1650 - Angiographic injector and syringe. II
§ 870.1660 - Indicator injector. II
§ 870.1670 - Syringe actuator for an injector. II
§ 870.1750 - External programmable pacemaker pulse generator. II
§ 870.1800 - Withdrawal-infusion pump. II
§ 870.1875 - Stethoscope. I/II
§ 870.1915 - Thermodilution probe. II
Subpart C [Reserved]
Subpart C [Reserved]