Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005716001

FEI Number

3005716001

Entity Name

Agilent Technologies LDA

City/State/Country

Penang Pulau Pinang, MY

Establishment Address

Bayan Lepas Free Industrial Zone, Penang Pulau Pinang 11900, MY

Establishment Type(s)

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

Owner / Operator

Agilent Technologies, Inc (Owner Number: 10038794)

Owner / Operator Contact Address

5301 Stevens Creek Blvd, Santa Clara, CA 95051, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dako Omnis 165 Dako Omnis Waste Tank (Hz) Dako Omnis Waste Container Steel Dako Omnis Certified Pre-Owned, RoHS Dako Omnis Buffer/Solvent Container Label User-Fillable Reagent Bottle 12mL Capacity (Link) User-Fillable Reagent Bottle 50mL Capacity (Link) Dako Omnis Dako Omnis Reagent Rack Dako Omnis ISH Lid Dako Omnis Slide Racks, 6 pcs User-Fillable Reagent Bottle 5mL Capacity (Link) Dako Coverstainer Slide Rack Artisan Link Autostainer Plus Link, Calibration Bottle Kit Dako Omnis Buffer/Solvent Container Dako CoverStainer Dako CoverStainer Dip Tank Dako Omnis Vial with Mixing Ball, 2 mL Dako Omnis Water container Autostainer Link 48 Artisan Link Pro Dako Omnis Small Vial, 2 mL User-Fillable Reagent Bottle 25mL Capacity (Link) Dako Omnis Large Vial, 30 mL Artisan Filter Dako Distribution Plates, 2 pcs, CoverStainer Dako Omnis Mixing Device Dako Distribution Plates, 10 pcs, CoverStainer Autostainer Slide Racks, 4 Pack Dako Omnis DI Water Filling Accessories Dako Omnis 165 Duo Dako Omnis Clean Liquid System Hardware Dako Omnis Waste Accessories (Direct) Dako Omnis 110 Dako Omnis Waste Accessories (Indirect) Dako Omnis Waste Tank (NHz) Dako Omnis DI Water Tank Dako Omnis Waste Container 7 L Dako PT Link Pascal Hybridizer PT Link Dako PT Link (PT200) Pascal Quality Strips Hybridizer Humidity Control Strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2018-11-09
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2016-01-22

Official Correspondent

Widad Ghaben

US Agent Details

Widad Ghaben Business: Agilent Technologies Email: enterprise.regulatory@agilent.com Phone: (408) 5537305

Related Public Records

Same Entity

Agilent Technologies, Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009202467	Agilent Technologies	Waldbronn Baden-Wurttemberg, DE
3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK
1217454	Agilent Technologies, Inc.	Winooski, VT, US
3003423869	Agilent Technologies Singapore (International) Pte Ltd.	Singapore North East, SG
2916205	Agilent Technologies, Inc	Santa Clara, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

Registration Number	Establishment Name	Location
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3009596884	DAGATRONICS CORPORATION	Goyang Gyeonggi, KR
3016621374	Jiangsu Medomics Medical Technology Co., Ltd.	Nanjing Jiangsu, CN
3016438761	ABBOTT LABORATORIES	Irving, TX, US
3017439370	SHENZHEN DARTMON BIOTECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005716001. Last updated year: 2026. Please use registration number 3005716001 when referencing this establishment in official correspondence.