The Dot Printer Inc.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3011057574

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011057574
FEI Number
3011057574
Entity Name
The Dot Printer Inc.
City/State/Country
Irvine, CA, US
Establishment Address
9700 Toledo Way, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device
Owner / Operator
The Dot Corp (Owner Number: 10049851)
Owner / Operator Contact Address
9700 Toledo Way, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LABCORP Microalbumin Kit UTI Convenience Kit LABCORP Fit KIT Alinity M Resp 4plex AMP Kit STI COLLECTION KIT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2015-08-12
OYJ Dna Specimen Collection, Saliva Clinical Chemistry Class 2 862.1675 2024-08-20
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2017-11-16
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Microbiology Class 2 866.3981 2024-04-29
OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2024-12-09

Official Correspondent

Jeffrey Shattuck

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

The Dot Corp
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011057574. Last updated year: 2026. Please use registration number 3011057574 when referencing this establishment in official correspondence.
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