A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinica
| Company | Devices | Share |
|---|---|---|
| Agilent Technologies, Inc. | 427 | 86% |
| Abbott Molecular Inc. | 23 | 5% |
| Life Technologies Corporation | 12 | 2% |
| Ventana Medical Systems, Inc. | 11 | 2% |
| Leica Biosystems Newcastle Ltd | 6 | 1% |
| Life Technologies, Corporation | 6 | 1% |
| Life Technologies Holdings Pte. Ltd. | 4 | 1% |
| Sakura Finetek U.S.A., Inc. | 3 | 1% |
| Biocare Medical Llc | 2 | 0% |
Company = labeler of record on GUDID. 9 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 |
|---|---|---|
| MVU | Reagents, specific, analyte | 760 |
| PPM | General purpose reagent | 23 |
| PCA | DNA genetic analyzer | 11 |
| PPM | General Purpose Reagent | 8 |
| PFT | Reagents for molecular diagnostic test systems | 5 |
| NJT | IMMUNOHISTOCHEMISTRY REAGENTS AND KITS | 4 |
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494 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Nucleic acid hybridization detection IVD, reagent", from 9 companies. The largest labeler is Agilent Technologies, Inc. with 86% of records.
MVU (Reagents, specific, analyte), PPM (General purpose reagent), PCA (DNA genetic analyzer), PPM (General Purpose Reagent)
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.