Data / Medical devices / United States / The Dot Printer Inc.

The Dot Printer Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance

Name: The Dot Printer Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Dot Printer Inc. is registered with the FDA (registration 3011057574) in Irvine, CA, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 14, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011057574
Address: 9700 Toledo Way, Irvine, CA, United States, 92618
Owner or operator: The Dot Corp (10049851)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: August 12, 2015
Registered through: 2026
Brand names listed: Alinity M Resp 4plex AMP Kit, Biomark Test, LABCORP Fit KIT, LABCORP Microalbumin Kit, STI COLLECTION KIT, T1 Diabetes, UTI Convenience Kit

Devices it lists

Device	Product code	Class	Role	Source
Blood And Urine Collection Kit (Excludes Hiv Testing)	OIB	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Blood Specimen Collection Convenience Kit (Excludes Hiv)	PQD	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Blood Specimen Collection Kit (Excludes Hiv Testing)	OFZ	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen Mailer And Storage, Non-Sterile	NNK	1	Repackager or relabeler	accessdata.fda.gov
Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile	NNL	1	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Dna Specimen Collection, Saliva	OYJ	2	Repackager or relabeler	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Reagents, Non-Variola Orthopoxvirus Nucleic Acid.	QTQ	N	Contract manufacturer, Repackager or relabeler	accessdata.fda.gov
Urine Collection Kit (Excludes Hiv Testing)	OIE	1	Contract manufacturer, Repackager or relabeler	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 14, 2020	K192920	Oragene®Dx	OYJ	Substantially Equivalent	DNA Genotek, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 14, 2020. 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.