A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin in a clinical specimen, using an enzyme immunoassay (EIA) method.
| Company | Devices | Share |
|---|---|---|
| Zeus Scientific, Inc. | 14 | 23% |
| Inova Diagnostics, Inc. | 10 | 16% |
| Aesku.Diagnostics Gmbh & Co. Kg | 5 | 8% |
| Drg Instruments Gesellschaft Mit Beschränkter Haftung | 5 | 8% |
| Corgenix Medical Corporation | 5 | 8% |
| Drg International Inc | 5 | 8% |
| Immuno Concepts Inc | 5 | 8% |
| Svar Life Science Ab | 3 | 5% |
| Bio-Rad Laboratories, Inc. | 3 | 5% |
| Instrumentation Laboratory Company | 3 | 5% |
| Thera-Test Laboratories, Inc | 2 | 3% |
| Quest International, Inc. | 2 | 3% |
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 |
|---|---|---|
| MID | System, Test, Anticardiolipin Immunological | 47 |
| MID | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 7 |
| MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 3 |
| DHC | SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS | 3 |
| GGW | Test, Time, Partial Thromboplastin | 1 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)", from 12 companies. The largest labeler is Zeus Scientific, Inc. with 23% of records.
MID (System, Test, Anticardiolipin Immunological), MID (SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL), MSV (System,test,antibodies,b2 - glycoprotein i (b2 - gpi)), DHC (SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS)
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.