Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009976420

FEI Number

3009976420

Entity Name

LIFE TECHNOLOGIES CORPORATION

City/State/Country

Pleasanton, CA, US

Establishment Address

6055 Sunol Blvd, Pleasanton, CA 94566, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Life Technologies Corporation (Owner Number: 9915045)

Owner / Operator Contact Address

5781 Van Allen Way, --, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233453

PMA Number

N/A

All Registered Proprietary Names

TaqPath COVID-19, FluA, FluB Combo Kit TaqPath COVID-19 Combo Kit TaqPath COVID-19 High Throughput Combo Kit TaqPath COVID-19 Fast PCR Combo Kit 2 TaqPath COVID-19 RNase P Combo Kit 2 TaqPath COVID-19 Diagnostic PCR Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-03-30
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2024-10-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Life Technologies Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1317268	Life Technologies Corporation	GRAND ISLAND, NY, US
3015529000	LIFE TECHNOLOGIES CORPORATION	Guilford, CT, US
3009207631	LIFE TECHNOLOGIES CORPORATION	Austin, TX, US
3009573214	Thermo Fisher Scientific Baltics UAB	Vilnius Vilniaus Miestas, LT
3003673482	Life Technologies Holdings Pte Ltd.	SINGAPORE North West, SG

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0008-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009976420. Last updated year: 2026. Please use registration number 3009976420 when referencing this establishment in official correspondence.