Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042971506

FEI Number

3042971506

Entity Name

PRECISION SYSTEM SCIENCE COMPANY LIMITED Odate Reagent Center

City/State/Country

Odate-shi Akita, JP

Establishment Address

40-31 Maeda, Hanaoka-machi, Odate-shi Akita 017-0005, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRECISION SYSTEM SCIENCE COMPANY LIMITED (Owner Number: 10027605)

Owner / Operator Contact Address

88 Kamihongou, Matsudo-shi, JP-12 271-0064, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elite InGenius SP 200 Elite InGenius Waste Box Elite InGenius Elite InGenius SP 200 Consumable Elite InGenius PCR Cassette

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2022-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

Derek Wessman Business: Jataki Company LLC Email: usagent@jataki.com Phone: (801) 6569278

Related Public Records

Same Entity

PRECISION SYSTEM SCIENCE COMPANY LIMITED

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005748564	PRECISION SYSTEM SCIENCE COMPANY LIMITED	Matsudo-city Chiba, JP

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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 3042971506. Last updated year: 2026. Please use registration number 3042971506 when referencing this establishment in official correspondence.