A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection for multiple types of antinuclear antibodies (ANA) in a clinical specimen, using a fluorescent immunoassay method.
| Company | Devices | Share |
|---|---|---|
| Immuno Concepts Inc | 143 | 64% |
| Immco Diagnostics, Inc. | 29 | 13% |
| Scimedx Corporation | 17 | 8% |
| Euroimmun Medizinische Labordiagnostika Ag | 9 | 4% |
| Aesku.Diagnostics Gmbh & Co. Kg | 5 | 2% |
| Hemagen Diagnostics, Inc. | 5 | 2% |
| Bio-Rad Laboratories, Inc. | 4 | 2% |
| Phadia Ab | 3 | 1% |
| Antibodies Incorporated | 3 | 1% |
| Bion Enterprises, Ltd. | 2 | 1% |
| Inova Diagnostics, Inc. | 1 | 0% |
| Diasorin Inc. | 1 | 0% |
Company = labeler of record on GUDID. 12 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 |
|---|---|---|
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, C | 60 |
| LKJ | Antinuclear Antibody, Antigen, Control | 19 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen | 12 |
| PIV | Automated Indirect Immunofluorescence Microscope And Softwar | 8 |
| LLL | EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL | 3 |
| DBM | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTI | 3 |
Use these as the dimensions to specify in a tender line.
222 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multiple antinuclear antibody (ANA) IVD, kit, fluorescent immunoassay", from 12 companies. The largest labeler is Immuno Concepts Inc with 64% of records.
DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, C), LKJ (Antinuclear Antibody, Antigen, Control), DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen), PIV (Automated Indirect Immunofluorescence Microscope And Softwar)
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.