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Life Technologies Corporation: FDA-registered device maker in Pleasanton, CA, United States, 2 510(k) clearances

Name: Life Technologies Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Life Technologies Corporation is registered with the FDA (registration 3009976420) in Pleasanton, CA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 8, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009976420
Address: 6055 Sunol Blvd, Pleasanton, CA, United States, 94566
Owner or operator: Life Technologies Corporation (9915045)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export
First device listed: March 30, 2020
Registered through: 2026
Brand names listed: Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel, Applied Biosystems TaqPath Seq HIV-1 Genotyping Kit, TaqPath COVID-19 Fast PCR Combo Kit 2, TaqPath COVID-19 RNase P Combo Kit 2, TaqPath COVID-19, FluA, FluB Combo Kit, TaqPath COVID-19 Diagnostic PCR Kit

Devices it lists

Device	Product code	Class	Role	Source
Assay, Genotype, Hiv Drug Resistance, In Vitro	NHS	2	Manufacturer for export	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Manufacturer	accessdata.fda.gov
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	QQX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 8, 2025	K241806	Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel	QOF	Substantially Equivalent	Life Technologies Corporation	accessdata.fda.gov
July 10, 2024	K233453	Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit	QQX	Substantially Equivalent	Life Technologies Corporation	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 6, 2020	86204	Class II	Terminated	The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detectio	COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.	accessdata.fda.gov

Compare with other makers

Updated January 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.