Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005655287

FEI Number

3005655287

Entity Name

IDS CO, LTD

City/State/Country

Kumamoto-Shi, JP

Establishment Address

8-14-30, Nagaminehigashi; Higashi-Ku, Kumamoto-Shi 861-8038, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IDS CO, LTD (Owner Number: 10049986)

Owner / Operator Contact Address

8-14-30 Nagaminehigashi, Higashi-ku, Kumamoto-shi, JP-43 861-8038, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Power Express Power Processor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2015-09-25
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2015-09-25
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2015-09-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-09-25
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2015-09-25
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2015-11-30
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-11-30
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2015-11-30
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2015-11-30
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2015-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Kessler Email: jhkessler@idsma.com Phone: (714) 4027202

Related Public Records

Same Entity

IDS CO, LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015969360	Kikuyo Factory	Kumamoto, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25
K151792	Siemens Healthcare Diagnostics, Inc.	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	2015-11-20
K141999	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR TSH	2015-04-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)

Similar Registrations

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005655287. Last updated year: 2026. Please use registration number 3005655287 when referencing this establishment in official correspondence.