An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i
| Company | Devices | Share |
|---|---|---|
| Hangzhou Bioer Technology Co., Ltd. | 17 | 11% |
| Life Technologies Holdings Pte. Ltd. | 16 | 10% |
| Cepheid | 13 | 8% |
| Targetingone Technology (Beijing) Corporation | 12 | 8% |
| Becton, Dickinson And Company | 12 | 8% |
| Roche Molecular Systems, Inc. | 11 | 7% |
| Biofire Diagnostics, Llc | 10 | 6% |
| Bio-Rad Laboratories, Inc. | 6 | 4% |
| Biofire Defense, Llc | 6 | 4% |
| Diasorin Molecular Llc | 6 | 4% |
| Bioneer Corporation | 6 | 4% |
| Qiagen Gmbh | 5 | 3% |
Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| OOI | Real Time Nucleic Acid Amplification System | 140 |
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococc | 37 |
| OOI | real time Nucleic acid amplification system | 31 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 28 |
| NSU | Instrumentation for clinical multiplex test systems | 10 |
| PHG | Droplet Digital Pcr System | 8 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
158 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Thermal cycler nucleic acid amplification analyser IVD, laboratory", from 34 companies. The largest labeler is Hangzhou Bioer Technology Co., Ltd. with 11% of records.
OOI (Real Time Nucleic Acid Amplification System), NJR (Nucleic Acid Amplification Assay System, Group B Streptococc), OOI (real time Nucleic acid amplification system), NSU (Instrumentation For Clinical Multiplex Test Systems)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.