FDA.reportPublic FDA data

OTSUKA ELECTRONICS CO., LTD.

Matched from indexed company URL: OTSUKA ELECTRONICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056220963005622096OTSUKA ELECTRONICS CO., LTD.1N2026-01-011-10, Sasagaoka, Minakuchi-cho Koka-city Shiga JP 528-0061

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04987035388517POC-AS10 Auto sampler - The POC-ASI10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.1-888-637-3835xx@xx.xx

Registered Device Listings#

Registration key, Listing key table
Registration keyListing key
3494121445620418

PMN#

GUDID#

POCone Infrared Spectrophotometer - 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.

OTSUKA ELECTRONICS CO.,LTD.

2019-10-30