OTSUKA ELECTRONICS CO.,LTD.

Address:1-10, Sasagaoka, Minakuchi-cho,Koka-city Shiga,JP

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (2)

Premarket Exempt

Clear

POCone Infrared Spectrophotometer - 04987035343417 Catalog Number :

Device Description : The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis.The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.

Device Class : 1

Duns Number: 695318717

Premarket Exempt : No

Product Code : JJQ

Prescription Use : No

Device Count : 1

POC-AS10 Auto sampler - 04987035388517 Catalog Number :

Device Description : The POC-ASI10 Auto sampler expands the number of breath collection bags that can The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.