Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000231747

FEI Number

1000231747

Entity Name

Takara Bio USA, Inc.

City/State/Country

San Jose, CA, US

Establishment Address

2560 Orchard Parkway, San Jose, CA 95131, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Takara Bio USA, Inc. (Owner Number: 10049222)

Owner / Operator Contact Address

2560 Orchard Parkway, San Jose, CA 95131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

5X PrimePath Probe qPCR Kit, no ROX, 200 rxns Lyo-Ready PrimePath Probe qPCR Mix, 100 rxns MMLV Reverse Transcriptase, 2000 Units MMLV Reverse Transcriptase, 20000 Units 5X PrimePath Probe qPCR Kit, ROX plus, 1000 rxns 5X One Step PrimeScript III RT-qPCR Kit, ROX plus, 1000 rxns 5X One Step PrimeScript III RT-qPCR Kit, no ROX, 200 rxns 5X One Step PrimeScript III RT-qPCR Kit, no ROX, 1000 rxns 5X One Step PrimeScript III RT-qPCR Kit, ROX plus, 200 rxns 5X PrimePath Probe qPCR Kit, ROX plus, 200 rxns MMLV Reverse Transcriptase, 8000 Units 5X PrimePath Probe qPCR Kit, no ROX, 1000 rxns

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2015-04-29

Official Correspondent

Loretta Momme

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Takara Bio USA, Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000231747. Last updated year: 2026. Please use registration number 1000231747 when referencing this establishment in official correspondence.