A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some ty
| Company | Devices | Share |
|---|---|---|
| Taiwan Advanced Nanotech Inc. | 124 | 26% |
| Genolution. Inc. | 39 | 8% |
| Hangzhou Bioer Technology Co., Ltd. | 33 | 7% |
| Magbio Genomics, Inc. | 31 | 6% |
| Qiagen Gmbh | 28 | 6% |
| Exact Sciences Corporation | 27 | 6% |
| Targetingone Technology (Beijing) Corporation | 25 | 5% |
| Entopsis, Llc | 19 | 4% |
| Jiangsu Bioperfectus Technologies Co., Ltd. | 17 | 4% |
| Sansure Biotech Inc. | 15 | 3% |
| Promega Corporation | 14 | 3% |
| Bioneer Corporation | 12 | 3% |
Company = labeler of record on GUDID. 37 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 |
|---|---|---|
| JJH | Clinical Sample Concentrator | 380 |
| PHP | System, Colorectal Neoplasia, Dna Methylation And Hemoglobin | 31 |
| PEG | Nucleic Acid Quantitation Kit | 24 |
| JJH | CLINICAL SAMPLE CONCENTRATOR | 23 |
| PPM | General Purpose Reagent | 11 |
| PFT | Reagents For Molecular Diagnostic Test Systems | 5 |
Use these as the dimensions to specify in a tender line.
478 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nucleic acid extraction/isolation kit IVD", from 37 companies. The largest labeler is Taiwan Advanced Nanotech Inc. with 26% of records.
JJH (Clinical Sample Concentrator), PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin), PEG (Nucleic Acid Quantitation Kit), JJH (CLINICAL SAMPLE CONCENTRATOR)
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.