Contract manufacturerThe Dot Printer Inc. (Irvine, CA)CaliforniaPathologyClinical chemistryMicrobiologyClass IClass IINot classified
The Dot Printer Inc.
Contract manufacturer · Irvine, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3011057574 (openFDA record; or search FDA's registration database)
- FEI number
- 3011057574
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer; Repackager or relabeler
- Owner or operator
- The Dot Corp (FDA owner/operator no. 10049851)
- Registered address
- 9700 Toledo Way, Irvine, CA 92618
- Contract listings
- 6 device listings, 6 product codes, first listed Aug 12, 2015
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| NNL | Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile | Class I | Pathology | Contract manufacturing | Mar 18, 2025 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | Class I | Pathology | Contract manufacturing | Dec 9, 2024 |
| OIE | Urine Collection Kit (Excludes Hiv Testing) | Class I | Pathology | Contract manufacturing | Aug 12, 2015 |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | Class II | Clinical chemistry | Contract manufacturing | Dec 9, 2024 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | Class II | Microbiology | Contract manufacturing | Apr 29, 2024 |
| QTQ | Reagents, Non-Variola Orthopoxvirus Nucleic Acid. | Not classified | Microbiology | Contract manufacturing | May 15, 2024 |