Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005181013

FEI Number

3005181013

Entity Name

TAKARA BIOTECHNOLOGY (DALIAN) CO., LTD.

City/State/Country

Dalian Liaoning, CN

Establishment Address

19-No. 2 Dongbei Street, Development Zone, Dalian Liaoning 116600, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Takara Biotechnology (Dalian) Co., Ltd. (Owner Number: 10049221)

Owner / Operator Contact Address

19-No. 2 Dongbei Street, Development Zone, Dalian, CN-LN 116600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MMLV Reverse Transcriptase, GPR (20,000 Units) MMLV Reverse Transcriptase, GPR (8000 Units) MMLV Reverse Transcriptase, GPR (2000 Units)

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

Loretta Momme Business: Takara Bio USA, Inc. Email: loretta_momme@takarabio.com Phone: (650) 9197436

Related Public Records

Same Entity

Takara Biotechnology (Dalian) Co., Ltd.

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3011661720	TRUCKEE APPLIED GENOMICS INC	Reno, NV, US
3005504113	KEMENTEC SOLUTIONS AS	Taastrup Hovedstaden, DK
3006537286	AUTOBIO DIAGNOSTICS CO., LTD.	Zhengzhou Henan, CN
3036685103	REAGENT	Runcorn Cheshire West and Chester, GB
3013452222	PREOMICS GMBH	Planegg/Martinsried Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005181013. Last updated year: 2026. Please use registration number 3005181013 when referencing this establishment in official correspondence.