A defined piece(s) of nucleic acid, typically tagged with a fluorescent marker, intended to be used for the detection of a specific target nucleotide sequence at a single-gene locus or whole/partial chromosome level in a clinical specimen, in order to identify
| Company | Devices | Share |
|---|---|---|
| Abbott Molecular Inc. | 247 | 44% |
| Leica Biosystems Newcastle Ltd | 197 | 35% |
| Biocare Medical Llc | 78 | 14% |
| Life Technologies Corporation | 18 | 3% |
| Cellay, Inc. | 11 | 2% |
| Biogenex Laboratories | 8 | 1% |
| Healthbio, Inc. | 3 | 1% |
| Ventana Medical Systems, Inc. | 1 | 0% |
Company = labeler of record on GUDID. 8 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 | 246 |
| MVU | Reagents, specific, analyte | 231 |
| MVU | Reagents, Specific, Analyte | 100 |
| NYQ | Chromogenic in situ hybridization, nucleic acid amplificatio | 1 |
Use these as the dimensions to specify in a tender line.
563 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, probe", from 8 companies. The largest labeler is Abbott Molecular Inc. with 44% of records.
MVU (REAGENTS,SPECIFIC,ANALYTE), MVU (Reagents, specific, analyte), MVU (Reagents, Specific, Analyte), NYQ (Chromogenic in situ hybridization, nucleic acid amplificatio)
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.