Data / Medical devices / High Throughput Dna Sequence Analyzer
High Throughput Dna Sequence Analyzer (PFF): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make High Throughput Dna Sequence Analyzer (product code PFF, Class 2, 21 CFR 862.2265). 2 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on June 22, 2017, and lists 9 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PFF
- Device class
- 2
- Regulation
- 862.2265
- Medical specialty
- Immunology
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Singapore | 3 |
Makers of High Throughput Dna Sequence Analyzer
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Illumina, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 19, 2013 | 0 | 6 | 0 | api.fda.gov |
| Illumina, Inc. Hayward | Hayward, CA, United States | Manufacturer | 1 | November 19, 2013 | 0 | 0 | 0 | api.fda.gov |
| Illumina Singapore Pte. Ltd. | Singapore Central Singapore, Singapore | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Austin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | S San Fran, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Guilford, CT, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Technologies Corporation | Frederick, MD, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Life Technologies Holdings Pte Ltd. | SINGAPORE North West, Singapore | Contract manufacturer, Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vela Operations Singapore Pte Ltd | Singapore Central Singapore, Singapore | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 22, 2017. 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.