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Life Technologies Corporation: FDA-registered device maker in S San Fran, CA, United States, 1 510(k) clearance and 1 PMA approval

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 3011104381) in S San Fran, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated July 2, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011104381
Address: 180 Oyster Point Blvd, S San Fran, CA, United States, 94080
Owner or operator: Life Technologies Corporation (9915045)
Roles: Specification developer
First device listed: March 13, 2013
Registered through: 2026
Brand names listed: 3500 Dx Capillary Array 50 cm, 3500 Dx Genetic Analyzer, 3500 Dx Series 96-Well Fast (0.1mL) Retainer & Base Set, 3500 Dx Series 96-Well Standard Retainer & Base Set, 3500 Dx Series Data Collection Software 3 IVD v3.2, 3500 Dx Series Polymer Pouch Caps, 3500 Dx Series Septa 96-Well, 3500 Dx Series Septa Cathode Buffer Container and more

Devices it lists

Device	Product code	Class	Role	Source
Dna Genetic Analyzer	PCA	2	Specification developer	accessdata.fda.gov
High Throughput Dna Sequence Analyzer	PFF	2	Specification developer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Specification developer	accessdata.fda.gov
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System	PQP	3	Specification developer	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Specification developer	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

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 2, 2025	P240040	Oncomine Dx Express Test	PQP	5	September 9, 2026	accessdata.fda.gov

Compare with other makers

Updated September 9, 2026. 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.