A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR in
| Company | Devices | Share |
|---|---|---|
| Becton, Dickinson And Company | 9 | 18% |
| Life Technologies Holdings Pte. Ltd. | 7 | 14% |
| Awareness Technology, Incorporated | 5 | 10% |
| Randox Laboratories Limited | 4 | 8% |
| Euroimmun Medizinische Labordiagnostika Ag | 4 | 8% |
| Instrumentation Laboratory Company | 4 | 8% |
| Siemens Healthcare Diagnostics Inc. | 3 | 6% |
| Helena Laboratories Corporation | 3 | 6% |
| Miris Ab | 2 | 4% |
| Horiba Abx Sas | 2 | 4% |
| Inova Diagnostics, Inc. | 2 | 4% |
| Clark Laboratories, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 17 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 |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Us | 9 |
| GKZ | Counter, differential cell | 7 |
| OOI | real time Nucleic acid amplification system | 7 |
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 5 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 4 |
| OYE | Flow cytometric reagents and accessories. | 4 |
Use these as the dimensions to specify in a tender line.
51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Optical laboratory instrument performance standard calibrator/control IVD, single-use", from 17 companies. The largest labeler is Becton, Dickinson And Company with 18% of records.
JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Us), GKZ (Counter, differential cell), OOI (real time Nucleic acid amplification system), JPA (SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES)
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.